AVANOS 35111Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00609038351117), received between Jun 11, 2021 and Oct 8, 2024 — classified as 3 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Separation Problem” (16 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2024Deflation Problem; Deflation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 3011270181-2024-00096 FOR THE FIRST REPORT REFER TO 3011270181-2024-00098 FOR THE THIRD REPORT REFER TO 3011270181-2024-00099 FOR THE FOURTH REPORT. IT WAS REPORTED, IT WAS REPORTED, MICRO-CUFF ENDOTRACHEAL TUBE (ETT), FOR PEDIATRICS DEFLATED; THERE WERE NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20402731 ↗
• InjuryOct 8, 2024Deflation Problem; Deflation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 3011270181-2024-00097 FOR THE SECOND REPORT REFER TO 3011270181-2024-00098 FOR THE THIRD REPORT REFER TO 3011270181-2024-00099 FOR THE FOURTH REPORT. IT WAS REPORTED, IT WAS REPORTED, THE MICRO-CUFF ENDOTRACHEAL TUBE (ETT) FOR PEDIATRICS DEFLATED; THERE WERE NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 24SEP2024 REPORTED, DESATURATION OCCURRED DURING ENDOTRACHEAL TUBE CHANGE, (NASAL INTUBATION FAILED DUE TO INCREASED SECRETION LOAD). THE PATIENT WAS REINTUBATED ON (B)(6) 2024. IT WAS ADDITIONALLY REPORTED, THE CHILD WAS STABLE BUT REMAINED INVASIVELY VENTILATED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 20402522 ↗
• InjuryJun 26, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED A NEW-BORN WAS TREATED FOR POSTNATAL DIAGNOSTIC ESOPHAGEAL ATRESIA WITH INFERIOR FISTULA. THE INTUBATION TUBE WAS TESTED BEFORE USE AND IT WAS [FOUND TO BE] FUNCTIONAL. IMMEDIATELY AFTER THE TUBE WAS PLACED, THE HEALTHCARE PROFESSIONAL NOTICED THAT THE INTUBATION TUBE BALLOON DEFLATED SPONTANEOUSLY AND THE PATIENT¿S EXHALED VENTILATORY PARAMETERS WERE LOW, WHICH WAS SYNONYMOUS WITH LEAKAGE. THE PATIENT WAS REINTUBATED AND GIVEN A SEQUENCE OF SUPPLEMENTAL MEDICATIONS (UNSPECIFIED). THE INTUBATION TUBE WAS REMOVED AND TESTED AND WAS FOUND TO BE DYSFUNCTIONAL. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED 06JUN2024, THERE WERE NO FURTHER CONSEQUENCES TO THE PATIENT, CONCERNING THE REPORTED EVENT. IT WAS ADDITIONALLY REPORTED, THE PATIENT REMAINS HOSPITALIZED FOR FURTHER TREATMENT, (THE PATIENT'S CURRENT CONDITION WAS NOT REPORTED).

  Patient problems: Decreased Respiratory Rate

  MAUDE report 19616463 ↗
• MalfunctionFeb 26, 2024Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED, THE CUFF PRESSURE DECREASED, AND UPON CHECKING, IT WAS DISCOVERED THAT THE INFLATING TUBE HAD BROKEN. IT WAS ADDITIONALLY REPORTED, THE DEVICE WAS PLACED IN (B)(6) 2023 AND DUE TO THE PATIENT¿S POOR CONDITION, IT WAS DIFFICULT TO REPLACE AND WAS IN USE UNTIL (B)(6) 2024. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18784263 ↗
• InjuryJan 5, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED, IN OCTOBER, THE PATIENT WAS INTUBATED WITH A CUFFED ETT, WHICH WAS NOTED TO HAVE MINIMAL OCCLUDING VOLUME. A CHEST X-RAY (CXR), FOR TUBE PLACEMENT, READ "THE TUBE WAS DEEP". A RESPIRATORY THERAPIST (RT) ATTEMPTED TO PULL THE TUBE BACK 1 CM AND NOTED HIGH PRESSURES ON THE VENT. GURGLING WAS HEARD DURING THE RTS ATTEMPT TO BAG THE BABY AND THE TUBE WAS BEING RETAPED (WITH NOTED DIFFICULTY); SECRETIONS COULD BE HEARD DURING THE SUCTION ATTEMPT; HOWEVER, THE TUBE DID NOT FEED ALL THE WAY IN AND ONLY A "LITTLE SECRETION" WAS RETURNED. THE SUCTION REGULATOR WAS CHANGED TWICE AND SUCTION WAS CONFIRMED. ETCO2 WAS CONFIRMED AND THEY ATTEMPTED TO INFLATE AND DEFLATE THE CUFF WITH NO IMPROVEMENT. THE RT PUT TENSION ON THE TUBE AND PULLED BACK TO 6 CM AND THINGS APPEARED TO IMPROVE; AN X-RAY WAS ORDERED. THE BABY BECAME DIFFICULT TO BAG AGAIN AND REQUIRED VERY HIGH PRESSURES; THE MEDICAL DOCTOR (MD) REMOVED THE TUBE; THE BABY WAS REINTUBATED WITH EASE AND TUBE PLACEMENT WAS VERIFIED WITH A CXR. ADDITIONAL INFORMATION RECEIVED 14DEC2023 REPORTED, THE ETT WAS IN PLACE FOR APPROXIMATELY 4 HOURS. ADDITIONAL INFORMATION RECEIVED 18DEC2023 REPORTED, A LOT OF FORCE WAS USED TO GET TH

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Respiratory Rate

  MAUDE report 18459744 ↗
• MalfunctionJun 22, 2023Separation Problem; Separation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN INCIDENCES, WHICH WERE ASSOCIATED WITH ONE DEVICE, INVOLVING THE SAME PATIENT. THIS IS THE TENTH OF TEN REPORTS. SEE 3011270181-2023-00079 FOR FIRST EVENT. SEE 3011270181-2023-00080 FOR SECOND EVENT. SEE 3011270181-2023-00081 FOR THIRD EVENT. SEE 3011270181-2023-00082 FOR FOURTH EVENT. SEE 3011270181-2023-00083 FOR FIFTH EVENT. SEE 3011270181-2023-00084 FOR SIXTH EVENT. SEE 3011270181-2023-00085 FOR SEVENTH EVENT. SEE 3011270181-2023-00086 FOR EIGHTH EVENT. SEE 3011270181-2023-00087 FOR NINTH EVENT. IT WAS REPORTED THAT THE MICROCUFF VENT CONNECTOR DETACHED FROM THE ENDOTRACHEAL TUBE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 07JUN2023, THE PATIENT WAS VERY ACTIVE AND MOVED A LOT. STAFF WAS PRESENT FOR ALL BUT ONE DISCONNECTION. THE BLUE TOP [VENT CONNECTOR] WAS IMMEDIATELY RECONNECTED. THE PATIENT DID NOT HAVE ANY ASSOCIATED DESATURATIONS. STAFF STAYED IN THE ROOM AT ALL TIMES DUE TO CONCERN TO PREVENT HARM TO THE PATIENT. THE PATIENT NOW HAS A TRACHEOSTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185948 ↗
• MalfunctionJun 22, 2023Separation Problem; Separation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN INCIDENCES, WHICH WERE ASSOCIATED WITH ONE DEVICE, INVOLVING THE SAME PATIENT. THIS IS THE NINTH OF TEN REPORTS. SEE 3011270181-2023-00079 FOR FIRST EVENT. SEE 3011270181-2023-00080 FOR SECOND EVENT. SEE 3011270181-2023-00081 FOR THIRD EVENT. SEE 3011270181-2023-00082 FOR FOURTH EVENT. SEE 3011270181-2023-00083 FOR FIFTH EVENT. SEE 3011270181-2023-00084 FOR SIXTH EVENT. SEE 3011270181-2023-00085 FOR SEVENTH EVENT. SEE 3011270181-2023-00086 FOR EIGHTH EVENT. SEE 3011270181-2023-00088 FOR TENTH EVENT. IT WAS REPORTED THAT THE MICROCUFF VENT CONNECTOR DETACHED FROM THE ENDOTRACHEAL TUBE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6)2023, THE PATIENT WAS VERY ACTIVE AND MOVED A LOT. STAFF WAS PRESENT FOR ALL BUT ONE DISCONNECTION. THE BLUE TOP [VENT CONNECTOR] WAS IMMEDIATELY RECONNECTED. THE PATIENT DID NOT HAVE ANY ASSOCIATED DESATURATIONS. STAFF STAYED IN THE ROOM AT ALL TIMES DUE TO CONCERN TO PREVENT HARM TO THE PATIENT. THE PATIENT NOW HAS A TRACHEOSTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185872 ↗
• MalfunctionJun 22, 2023Separation Problem; Separation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN INCIDENCES, WHICH WERE ASSOCIATED WITH ONE DEVICE, INVOLVING THE SAME PATIENT. THIS IS THE EIGHTH OF TEN REPORTS. SEE 3011270181-2023-00079 FOR FIRST EVENT. SEE 3011270181-2023-00080 FOR SECOND EVENT. SEE 3011270181-2023-00081 FOR THIRD EVENT. SEE 3011270181-2023-00082 FOR FOURTH EVENT. SEE 3011270181-2023-00083 FOR FIFTH EVENT. SEE 3011270181-2023-00084 FOR SIXTH EVENT. SEE 3011270181-2023-00085 FOR SEVENTH EVENT. SEE 3011270181-2023-00087 FOR NINTH EVENT. SEE 3011270181-2023-00088 FOR TENTH EVENT. IT WAS REPORTED THAT THE MICROCUFF VENT CONNECTOR DETACHED FROM THE ENDOTRACHEAL TUBE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 07JUN2023, THE PATIENT WAS VERY ACTIVE AND MOVED A LOT. STAFF WAS PRESENT FOR ALL BUT ONE DISCONNECTION. THE BLUE TOP [VENT CONNECTOR] WAS IMMEDIATELY RECONNECTED. THE PATIENT DID NOT HAVE ANY ASSOCIATED DESATURATIONS. STAFF STAYED IN THE ROOM AT ALL TIMES DUE TO CONCERN TO PREVENT HARM TO THE PATIENT. THE PATIENT NOW HAS A TRACHEOSTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185864 ↗
• MalfunctionJun 22, 2023Separation Problem; Separation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN INCIDENCES, WHICH WERE ASSOCIATED WITH ONE DEVICE, INVOLVING THE SAME PATIENT. THIS IS THE SIXTH OF TEN REPORTS. SEE 3011270181-2023-00079 FOR FIRST EVENT. SEE 3011270181-2023-00080 FOR SECOND EVENT. SEE 3011270181-2023-00081 FOR THIRD EVENT. SEE 3011270181-2023-00082 FOR FOURTH EVENT. SEE 3011270181-2023-00083 FOR FIFTH EVENT. SEE 3011270181-2023-00085 FOR SEVENTH EVENT. SEE 3011270181-2023-00086 FOR EIGHTH EVENT. SEE 3011270181-2023-00087 FOR NINTH EVENT. SEE 3011270181-2023-00088 FOR TENTH EVENT. IT WAS REPORTED THAT THE MICROCUFF VENT CONNECTOR DETACHED FROM THE ENDOTRACHEAL TUBE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 07JUN2023, THE PATIENT WAS VERY ACTIVE AND MOVED A LOT. STAFF WAS PRESENT FOR ALL BUT ONE DISCONNECTION. THE BLUE TOP [VENT CONNECTOR] WAS IMMEDIATELY RECONNECTED. THE PATIENT DID NOT HAVE ANY ASSOCIATED DESATURATIONS. STAFF STAYED IN THE ROOM AT ALL TIMES DUE TO CONCERN TO PREVENT HARM TO THE PATIENT. THE PATIENT NOW HAS A TRACHEOSTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185835 ↗
• MalfunctionJun 22, 2023Separation Problem; Separation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN INCIDENCES, WHICH WERE ASSOCIATED WITH ONE DEVICE, INVOLVING THE SAME PATIENT. THIS IS THE SEVENTH OF TEN REPORTS. SEE 3011270181-2023-00079 FOR FIRST EVENT. SEE 3011270181-2023-00080 FOR SECOND EVENT. SEE 3011270181-2023-00081 FOR THIRD EVENT. SEE 3011270181-2023-00082 FOR FOURTH EVENT. SEE 3011270181-2023-00083 FOR FIFTH EVENT. SEE 3011270181-2023-00084 FOR SIXTH EVENT. SEE 3011270181-2023-00086 FOR EIGHTH EVENT. SEE 3011270181-2023-00087 FOR NINTH EVENT. SEE 3011270181-2023-00088 FOR TENTH EVENT. IT WAS REPORTED THAT THE MICROCUFF VENT CONNECTOR DETACHED FROM THE ENDOTRACHEAL TUBE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023, THE PATIENT WAS VERY ACTIVE AND MOVED A LOT. STAFF WAS PRESENT FOR ALL BUT ONE DISCONNECTION. THE BLUE TOP [VENT CONNECTOR] WAS IMMEDIATELY RECONNECTED. THE PATIENT DID NOT HAVE ANY ASSOCIATED DESATURATIONS. STAFF STAYED IN THE ROOM AT ALL TIMES DUE TO CONCERN TO PREVENT HARM TO THE PATIENT. THE PATIENT NOW HAS A TRACHEOSTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185827 ↗
• MalfunctionJun 22, 2023Separation Problem; Separation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN INCIDENCES, WHICH WERE ASSOCIATED WITH ONE DEVICE, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TEN REPORTS. SEE 3011270181-2023-00079 FOR FIRST EVENT. SEE 3011270181-2023-00081 FOR THIRD EVENT. SEE 3011270181-2023-00082 FOR FOURTH EVENT. SEE 3011270181-2023-00083 FOR FIFTH EVENT. SEE 3011270181-2023-00084 FOR SIXTH EVENT. SEE 3011270181-2023-00085 FOR SEVENTH EVENT. SEE 3011270181-2023-00086 FOR EIGHTH EVENT. SEE 3011270181-2023-00087 FOR NINTH EVENT. SEE 3011270181-2023-00088 FOR TENTH EVENT. IT WAS REPORTED THAT THE MICROCUFF VENT CONNECTOR DETACHED FROM THE ENDOTRACHEAL TUBE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 07JUN2023, THE PATIENT WAS VERY ACTIVE AND MOVED A LOT. STAFF WAS PRESENT FOR ALL BUT ONE DISCONNECTION. THE BLUE TOP [VENT CONNECTOR] WAS IMMEDIATELY RECONNECTED. THE PATIENT DID NOT HAVE ANY ASSOCIATED DESATURATIONS. STAFF STAYED IN THE ROOM AT ALL TIMES DUE TO CONCERN TO PREVENT HARM TO THE PATIENT. THE PATIENT NOW HAS A TRACHEOSTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185821 ↗
• MalfunctionJun 22, 2023Separation Problem; Separation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN INCIDENCES, WHICH WERE ASSOCIATED WITH ONE DEVICE, INVOLVING THE SAME PATIENT. THIS IS THE FIFTH OF TEN REPORTS. SEE 3011270181-2023-00079 FOR FIRST EVENT. SEE 3011270181-2023-00080 FOR SECOND EVENT. SEE 3011270181-2023-00081 FOR THIRD EVENT. SEE 3011270181-2023-00082 FOR FOURTH EVENT. SEE 3011270181-2023-00084 FOR SIXTH EVENT. SEE 3011270181-2023-00085 FOR SEVENTH EVENT. SEE 3011270181-2023-00086 FOR EIGHTH EVENT. SEE 3011270181-2023-00087 FOR NINTH EVENT. SEE 3011270181-2023-00088 FOR TENTH EVENT. IT WAS REPORTED THAT THE MICROCUFF VENT CONNECTOR DETACHED FROM THE ENDOTRACHEAL TUBE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 07JUN2023, THE PATIENT WAS VERY ACTIVE AND MOVED A LOT. STAFF WAS PRESENT FOR ALL BUT ONE DISCONNECTION. THE BLUE TOP [VENT CONNECTOR] WAS IMMEDIATELY RECONNECTED. THE PATIENT DID NOT HAVE ANY ASSOCIATED DESATURATIONS. STAFF STAYED IN THE ROOM AT ALL TIMES DUE TO CONCERN TO PREVENT HARM TO THE PATIENT. THE PATIENT NOW HAS A TRACHEOSTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185775 ↗
• MalfunctionJun 22, 2023Separation Problem; Separation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN INCIDENCES, WHICH WERE ASSOCIATED WITH ONE DEVICE, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF TEN REPORTS. SEE 3011270181-2023-00079 FOR FIRST EVENT. SEE 3011270181-2023-00080 FOR SECOND EVENT. SEE 3011270181-2023-00082 FOR FOURTH EVENT. SEE 3011270181-2023-00083 FOR FIFTH EVENT. SEE 3011270181-2023-00084 FOR SIXTH EVENT. SEE 3011270181-2023-00085 FOR SEVENTH EVENT. SEE 3011270181-2023-00086 FOR EIGHTH EVENT. SEE 3011270181-2023-00087 FOR NINTH EVENT. SEE 3011270181-2023-00088 FOR TENTH EVENT. IT WAS REPORTED THAT THE MICROCUFF VENT CONNECTOR DETACHED FROM THE ENDOTRACHEAL TUBE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6)2023, THE PATIENT WAS VERY ACTIVE AND MOVED A LOT. STAFF WAS PRESENT FOR ALL BUT ONE DISCONNECTION. THE BLUE TOP [VENT CONNECTOR] WAS IMMEDIATELY RECONNECTED. THE PATIENT DID NOT HAVE ANY ASSOCIATED DESATURATIONS. STAFF STAYED IN THE ROOM AT ALL TIMES DUE TO CONCERN TO PREVENT HARM TO THE PATIENT. THE PATIENT NOW HAS A TRACHEOSTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185766 ↗
• MalfunctionJun 22, 2023Separation Problem; Separation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN INCIDENCES, WHICH WERE ASSOCIATED WITH ONE DEVICE, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TEN REPORTS. SEE 3011270181-2023-00080 FOR SECOND EVENT. SEE 3011270181-2023-00081 FOR THIRD EVENT. SEE 3011270181-2023-00082 FOR FOURTH EVENT. SEE 3011270181-2023-00083 FOR FIFTH EVENT. SEE 3011270181-2023-00084 FOR SIXTH EVENT. SEE 3011270181-2023-00085 FOR SEVENTH EVENT. SEE 3011270181-2023-00086 FOR EIGHTH EVENT. SEE 3011270181-2023-00087 FOR NINTH EVENT. SEE 3011270181-2023-00088 FOR TENTH EVENT. IT WAS REPORTED THAT THE MICROCUFF VENT CONNECTOR DETACHED FROM THE ENDOTRACHEAL TUBE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023, THE PATIENT WAS VERY ACTIVE AND MOVED A LOT. STAFF WAS PRESENT FOR ALL BUT ONE DISCONNECTION. THE BLUE TOP [VENT CONNECTOR] WAS IMMEDIATELY RECONNECTED. THE PATIENT DID NOT HAVE ANY ASSOCIATED DESATURATIONS. STAFF STAYED IN THE ROOM AT ALL TIMES DUE TO CONCERN TO PREVENT HARM TO THE PATIENT. THE PATIENT NOW HAS A TRACHEOSTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185716 ↗
• MalfunctionJun 22, 2023Separation Problem; Separation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN INCIDENCES, WHICH WERE ASSOCIATED WITH ONE DEVICE, INVOLVING THE SAME PATIENT. THIS IS THE FOURTH OF TEN REPORTS. SEE 3011270181-2023-00079 FOR FIRST EVENT. SEE 3011270181-2023-00080 FOR SECOND EVENT. SEE 3011270181-2023-00081 FOR THIRD EVENT. SEE 3011270181-2023-00083 FOR FIFTH EVENT. SEE 3011270181-2023-00084 FOR SIXTH EVENT. SEE 3011270181-2023-00085 FOR SEVENTH EVENT. SEE 3011270181-2023-00086 FOR EIGHTH EVENT. SEE 3011270181-2023-00087 FOR NINTH EVENT. SEE 3011270181-2023-00088 FOR TENTH EVENT. IT WAS REPORTED THAT THE MICROCUFF VENT CONNECTOR DETACHED FROM THE ENDOTRACHEAL TUBE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 07JUN2023, THE PATIENT WAS VERY ACTIVE AND MOVED A LOT. STAFF WAS PRESENT FOR ALL BUT ONE DISCONNECTION. THE BLUE TOP [VENT CONNECTOR] WAS IMMEDIATELY RECONNECTED. THE PATIENT DID NOT HAVE ANY ASSOCIATED DESATURATIONS. STAFF STAYED IN THE ROOM AT ALL TIMES DUE TO CONCERN TO PREVENT HARM TO THE PATIENT. THE PATIENT NOW HAS A TRACHEOSTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185667 ↗
• MalfunctionJun 19, 2023Separation Problem; Separation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE INCIDENCES, WHICH WERE ASSOCIATED WITH TWO SEPARATE DEVICES, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. SEE 3011270181-2023-00095 FOR FIRST EVENT. SEE 3011270181-2023-00096 FOR SECOND EVENT. IT WAS REPORTED, "BLUE TOP OF ENDOTRACHEAL TUBE (ETT) COMES OUT OF ETT EVERY TIME PATIENT IS DISCONNECTED FOR SUCTIONING. THIS THEN HAS TO BE REINSERTED FOR SUCTIONING. THEREBY ADDING TO PATIENT'S DISCONNECTION TIME FROM VENTILATOR." NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17151301 ↗
• MalfunctionJun 19, 2023Separation Problem; Separation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE INCIDENCES, WHICH WERE ASSOCIATED WITH TWO SEPARATE DEVICES, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. SEE 3011270181-2023-00096 FOR SECOND EVENT. SEE 3011270181-2023-00097 FOR THIRD EVENT. IT WAS REPORTED, ENDOTRACHEAL TUBE (ETT) MICROCUFF WITH BLUE TOP DISCONNECTED FROM VENTILATOR. THE BLUE CAP CAME OUT OF ETT. BEDSIDE NURSE WAS ON BREAK. PATIENT DESATURATED TO 82%. BLUE TOP REINSERTED INTO ETT AND RECONNECTED TO VENTILATOR. SUCTION SUPPORT GIVEN AND OXYGEN SATURATIONS RECOVERED¿.

  Patient problems: Low Oxygen Saturation

  MAUDE report 17151271 ↗
• MalfunctionJun 19, 2023Separation Problem; Separation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE INCIDENCES, WHICH WERE ASSOCIATED WITH TWO SEPARATE DEVICES, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. SEE 3011270181-2023-00095 FOR FIRST EVENT. SEE 3011270181-2023-00097 FOR THIRD EVENT. IT WAS REPORTED, "BLUE TOP OF ENDOTRACHEAL TUBE (ETT) COMES OUT OF ETT EVERY TIME PATIENT IS DISCONNECTED FOR SUCTIONING. THIS THEN HAS TO BE REINSERTED FOR SUCTIONING. THEREBY ADDING TO PATIENT'S DISCONNECTION TIME FROM VENTILATOR." NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17151267 ↗
• MalfunctionMay 3, 2023Disconnection; Disconnection

  IT WAS REPORTED VIA FDA UF# 4100070000-2023-8011: "PATIENT WAS INTUBATED WITH 3.0 ETT. WHILE AT MRI, BLUE CAP FROM END OF ETT SEPARATED FROM TUBE THREE TIMES. PATIENT HAD DESATURATIONS ASSOCIATED WITH EACH EVENT AND REQUIRED MANUAL BAGGING AFTER BLUE CAP WAS REPLACED." APPROXIMATE AGE OF DEVICE WAS REPORTED AS 1 DAYS. LOCATION WHERE EVENT OCCURRED WAS REPORTED AS PICU HOSPITAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Hypoxia

  MAUDE report 16860933 ↗
• MalfunctionFeb 3, 2023Separation Problem; Separation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED 2 DIFFERENT INCIDENCES. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3011270181-2023-00009 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE TOP OF THE ENDOTRACHEAL TUBE CAME AWAY FROM THE ADAPTOR. IT IS UNKNOWN AT THIS TIME IF THE PATIENT WAS CONNECTED TO THE VENT CIRCUIT. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16291007 ↗
• MalfunctionFeb 3, 2023Separation Problem; Separation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3011270181-2023-00010 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE TOP OF THE ENDOTRACHEAL TUBE CAME AWAY FROM THE ADAPTOR. IT IS UNKNOWN AT THIS TIME IF THE PATIENT WAS CONNECTED TO THE VENT CIRCUIT. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16291004 ↗
• MalfunctionJan 27, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE TOP OF THE ENDOTRACHEAL TUBE CAME AWAY FROM THE ADAPTER. WHILE DISCONNECTING TO INITIATE HIGH-FREQUENCY OSCILLATORY VENTILATION (HFOV) FROM CONVENTIONAL, THE TIP DISCONNECTED FROM THE PATIENT RESULTING IN THE PATIENT NOT BEING VENTILATED, LOSING OXYGENATION, AND DROPPED OXYGEN SATURATION. NO MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 17 JAN 2023, THE PATIENT¿S OXYGEN SATURATION DECREASED TO 25%. FI02 WAS INCREASED. THE DEVICE WAS IN USE FOR APPROXIMATELY 48 HOURS. THE PATIENT HAS RECOVERED FROM THE INCIDENT.

  Patient problems: Hypoventilation; Hypoxia

  MAUDE report 16257413 ↗
• MalfunctionDec 13, 2022Disconnection; Disconnection

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 3011270181-2022-00085 FOR THE FIRST EVENT. REFER TO 3011270181-2022-00086 FOR THE SECOND EVENT. REFER TO 3011270181-2022-00087 FOR THE THIRD EVENT. REFER TO 3011270181-2022-00089 FOR THE FIFTH EVENT. IT WAS REPORTED THE ENDOTRACHEAL TUBE (ETT) DISCONNECTED FROM THE VENT CONNECTOR WHILE ATTACHED TO THE VENT CIRCUIT. NO ALTERATIONS WERE MADE TO THE ETT. THE DISCONNECT RESULTED IN THE VENTILATOR ALARMING. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969071 ↗
• MalfunctionDec 13, 2022Disconnection; Disconnection

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 3011270181-2022-00085 FOR THE FIRST EVENT. REFER TO 3011270181-2022-00087 FOR THE THIRD EVENT. REFER TO 3011270181-2022-00088 FOR THE FOURTH EVENT. REFER TO 3011270181-2022-00089 FOR THE FIFTH EVENT. IT WAS REPORTED THE ENDOTRACHEAL TUBE (ETT) DISCONNECTED FROM THE VENT CONNECTOR WHILE ATTACHED TO THE VENT CIRCUIT. NO ALTERATIONS WERE MADE TO THE ETT. THE DISCONNECT RESULTED IN THE VENTILATOR ALARMING. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969040 ↗
• MalfunctionDec 13, 2022Disconnection; Disconnection

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 3011270181-2022-00085 FOR THE FIRST EVENT. REFER TO 3011270181-2022-00086 FOR THE SECOND EVENT. REFER TO 3011270181-2022-00087 FOR THE THIRD EVENT. REFER TO 3011270181-2022-00088 FOR THE FOURTH EVENT. IT WAS REPORTED THE ENDOTRACHEAL TUBE (ETT) DISCONNECTED FROM THE VENT CONNECTOR WHILE ATTACHED TO THE VENT CIRCUIT. NO ALTERATIONS WERE MADE TO THE ETT. THE DISCONNECT RESULTED IN THE VENTILATOR ALARMING. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969024 ↗