Ballard* Closed Suction System 93833Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00609038938332), received between Feb 14, 2022 and Jul 17, 2026 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25864644 ↗
• MalfunctionFeb 29, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE TIP OF THE CLOSED SUCTION CATHETER (CSC) Y-ADAPTER BROKE INSIDE THE TIP OF THE 3.0 ENDOTRACHEAL (ETT), DURING USE. THE PATIENT WAS REPORTEDLY, "DIFFICULT TO VENTILATE" THE ETT WAS REMOVED, AND THE PATIENT WAS TRANSITIONED TO NONINVASIVE VENTILATION. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 06FEB2024 REPORTED, THE PATIENT WAS DOING WELL.

  Patient problems: Insufficient Information

  MAUDE report 18812936 ↗
• InjuryMar 22, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED, THE PEDIATRIC PATIENT WAS RUSHED TO THE EMERGENCY ROOM (ER) AS THE CATHETER WAS HARD TO PASS INTO THE TRACH AND THEY WERE NOT BEING ABLE TO CLEAR THE PATIENT¿S AIRWAY. THE CHILD REPORTEDLY TURNED BLUE, AND THE PATIENT¿S MOTHER CALLED 911; THE CHILD WAS ADMITTED FOR SEVERAL DAYS AND HAS SINCE RECOVERED.

  Patient problems: Airway Obstruction

  MAUDE report 16592521 ↗
• InjuryJan 24, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE PLASTIC SHEATH COVERING FOR THE INLINE BALLARD SUCTION CATHETER(S) BROKE, WHICH RESULTED IN A LOSS OF VENTILATOR PRESSURE TO THE INFANT; THE CAREGIVERS REPORTED THE MATERIAL SEEMED DIFFERENT. THE INFANTS¿ CURRENT CONDITION WAS NOT REPORTED.

  Patient problems: Hypoventilation

  MAUDE report 16233931 ↗
• MalfunctionSep 9, 2022Increase in Suction; Increase in Suction

  IT WAS REPORTED THAT ON (B)(6) 2022, "DURING PATIENT CARE RN NOTICED PATIENT (PT) END-TIDAL CARBON DIOXIDE (ETCO2) SUDDENLY LOW, TRICUSPID VALVE (TV) ON [THE] VENTILATOR BREATHS VERY LOW, AND PT WITH 99% LEAK. TRACHEOSTOMY TUBE (TRACH) PLACEMENT CHECKED AND INTACT, PT WITH GOOD BREATH SOUNDS, PT SATURATIONS STABLE AND PT PINK. ETCO2 MONITORING DEVICE CHANGED WITHOUT CHANGE TO ETCO2. RESPIRATORY CALLED TO CHECK VENT AND VOLUME IN CUFF ON TRACH. RESPIRATORY INFLATED CUFF TO CORRECT VOLUME BUT NO CHANGE IN ETCO2, TV OR LEAK. [THE] ATTENDING PHYSICIAN CALLED TO BEDSIDE AND ASKED FOR [THE] TRACH TO BE CHANGED. [THE] TRACH [WAS] CHANGED WITH [THE] ATTENDING, FELLOW, AND RESPIRATORY AT BEDSIDE WITHOUT ADVERSE EVENT, BUT ETCO2, TV AND LEAK UNCHANGED. ATTENDING ASKED FOR VENT AND TUBING TO BE CHANGED; AS VENT WAS BEING SET UP, [THE] RESPIRATORY THERAPIST [RT] ASSESSED [THE] IN-LINE SUCTION DEVICE AND DETERMINED THAT IT WAS NOT FUNCTIONING PROPERLY AND [THE] PT WAS CONTINUOUSLY GETTING SUCTION APPLIED TO VENT CIRCUIT. [THE] IN-LINE SUCTION DEVICE [WAS] CHANGED AND [THE] ETCO2 RETURNED TO NORMAL READING, TV AND RETURNED TO 4-6CC/KG AND LEAK WAS MINIMAL 2-3%. [THE] PT WAS STABLE THROUGHOUT EVE

  Patient problems: Hypoventilation

  MAUDE report 15392456 ↗
• MalfunctionAug 20, 2022Suction Failure; Suction Failure

  IT WAS REPORTED "THE RT THEN ATTEMPTED TO INLINE SUCTION THE PATIENT AS CLINICALLY INDICATED, HOWEVER THE INLINE CATHETER WOULD NOT COLLECT ANY SECRETIONS. THE SUCTION WAS VERIFIED/PATENT AND AT THE CORRECT SETTING. THE INLINE SUCTION WAS CHANGED TO A NEW DEVICE, WITH NO FURTHER PROBLEMS." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 28-JUL-2022 STATING IT WAS UNKNOWN HOW LONG THE CSC [CLOSED SUCTION CATHETER] HAD BEEN IN USE PRIOR TO THE REPORTED INCIDENT OCCURRING. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 15263348 ↗
• MalfunctionAug 8, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT EVENTS. THIS IS THE TENTH OF TEN REPORTS. REFER TO 8030647-2022-00173 FOR THE FIRST EVENT. REFER TO 8030647-2022-00174 FOR THE SECOND EVENT. REFER TO 8030647-2022-00175 FOR THE THIRD EVENT. REFER TO 8030647-2022-00176 FOR THE FOURTH EVENT. REFER TO 8030647-2022-00177 FOR THE FIFTH EVENT. REFER TO 8030647-2022-00178 FOR THE SIXTH EVENT. REFER TO 8030647-2022-00179 FOR THE SEVENTH EVENT. REFER TO 8030647-2022-00180 FOR THE EIGHTH EVENT. REFER TO 8030647-2022-00181 FOR THE NINTH EVENT. IT WAS REPORTED THE SUCTION CATHETER WAS UNABLE TO SUCTION ANYTHING, EVEN WATER WAS TRIED BY CAREGIVER. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15189424 ↗
• MalfunctionAug 8, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT EVENTS. THIS IS THE NINTH OF TEN REPORTS. REFER TO 8030647-2022-00173 FOR THE FIRST EVENT. REFER TO 8030647-2022-00174 FOR THE SECOND EVENT. REFER TO 8030647-2022-00175 FOR THE THIRD EVENT. REFER TO 8030647-2022-00176 FOR THE FOURTH EVENT. REFER TO 8030647-2022-00177 FOR THE FIFTH EVENT. REFER TO 8030647-2022-00178 FOR THE SIXTH EVENT. REFER TO 8030647-2022-00179 FOR THE SEVENTH EVENT. REFER TO 8030647-2022-00180 FOR THE EIGHTH EVENT. REFER TO 8030647-2022-00182 FOR THE TENTH EVENT. IT WAS REPORTED THE SUCTION CATHETER WAS UNABLE TO SUCTION ANYTHING, EVEN WATER WAS TRIED BY CAREGIVER. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15189423 ↗
• MalfunctionAug 8, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT EVENTS. THIS IS THE EIGHTH OF TEN REPORTS. REFER TO 8030647-2022-00173 FOR THE FIRST EVENT. REFER TO 8030647-2022-00174 FOR THE SECOND EVENT. REFER TO 8030647-2022-00175 FOR THE THIRD EVENT. REFER TO 8030647-2022-00176 FOR THE FOURTH EVENT. REFER TO 8030647-2022-00177 FOR THE FIFTH EVENT. REFER TO 8030647-2022-00178 FOR THE SIXTH EVENT. REFER TO 8030647-2022-00179 FOR THE SEVENTH EVENT. REFER TO 8030647-2022-00181 FOR THE NINTH EVENT. REFER TO 8030647-2022-00182 FOR THE TENTH EVENT. IT WAS REPORTED THE SUCTION CATHETER WAS UNABLE TO SUCTION ANYTHING, EVEN WATER WAS TRIED BY CAREGIVER. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15189420 ↗
• MalfunctionAug 8, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT EVENTS. THIS IS THE SEVENTH OF TEN REPORTS. REFER TO 8030647-2022-00173 FOR THE FIRST EVENT. REFER TO 8030647-2022-00174 FOR THE SECOND EVENT. REFER TO 8030647-2022-00175 FOR THE THIRD EVENT. REFER TO 8030647-2022-00176 FOR THE FOURTH EVENT. REFER TO 8030647-2022-00177 FOR THE FIFTH EVENT. REFER TO 8030647-2022-00178 FOR THE SIXTH EVENT. REFER TO 8030647-2022-00180 FOR THE EIGHTH EVENT. REFER TO 8030647-2022-00181 FOR THE NINTH EVENT. REFER TO 8030647-2022-00182 FOR THE TENTH EVENT. IT WAS REPORTED THE SUCTION CATHETER WAS UNABLE TO SUCTION ANYTHING, EVEN WATER WAS TRIED BY CAREGIVER. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15189419 ↗
• MalfunctionAug 8, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT EVENTS. THIS IS THE FIFTH OF TEN REPORTS. REFER TO 8030647-2022-00173 FOR THE FIRST EVENT. REFER TO 8030647-2022-00174 FOR THE SECOND EVENT. REFER TO 8030647-2022-00175 FOR THE THIRD EVENT. REFER TO 8030647-2022-00176 FOR THE FOURTH EVENT. REFER TO 8030647-2022-00178 FOR THE SIXTH EVENT. REFER TO 8030647-2022-00179 FOR THE SEVENTH EVENT. REFER TO 8030647-2022-00180 FOR THE EIGHTH EVENT. REFER TO 8030647-2022-00181 FOR THE NINTH EVENT. REFER TO 8030647-2022-00182 FOR THE TENTH EVENT. IT WAS REPORTED THE SUCTION CATHETER WAS UNABLE TO SUCTION ANYTHING, EVEN WATER WAS TRIED BY CAREGIVER. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15189416 ↗
• MalfunctionAug 8, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT EVENTS. THIS IS THE SIXTH OF TEN REPORTS. REFER TO 8030647-2022-00173 FOR THE FIRST EVENT. REFER TO 8030647-2022-00174 FOR THE SECOND EVENT. REFER TO 8030647-2022-00175 FOR THE THIRD EVENT. REFER TO 8030647-2022-00176 FOR THE FOURTH EVENT. REFER TO 8030647-2022-00177 FOR THE FIFTH EVENT. REFER TO 8030647-2022-00179 FOR THE SEVENTH EVENT. REFER TO 8030647-2022-00180 FOR THE EIGHTH EVENT. REFER TO 8030647-2022-00181 FOR THE NINTH EVENT. REFER TO 8030647-2022-00182 FOR THE TENTH EVENT. IT WAS REPORTED THE SUCTION CATHETER WAS UNABLE TO SUCTION ANYTHING, EVEN WATER WAS TRIED BY CAREGIVER. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15189415 ↗
• MalfunctionAug 8, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT EVENTS. THIS IS THE FOURTH OF TEN REPORTS. REFER TO 8030647-2022-00173 FOR THE FIRST EVENT. REFER TO 8030647-2022-00174 FOR THE SECOND EVENT. REFER TO 8030647-2022-00175 FOR THE THIRD EVENT. REFER TO 8030647-2022-00177 FOR THE FIFTH EVENT. REFER TO 8030647-2022-00178 FOR THE SIXTH EVENT. REFER TO 8030647-2022-00179 FOR THE SEVENTH EVENT. REFER TO 8030647-2022-00180 FOR THE EIGHTH EVENT. REFER TO 8030647-2022-00181 FOR THE NINTH EVENT. REFER TO 8030647-2022-00182 FOR THE TENTH EVENT. IT WAS REPORTED THE SUCTION CATHETER WAS UNABLE TO SUCTION ANYTHING, EVEN WATER WAS TRIED BY CAREGIVER. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15189414 ↗
• MalfunctionAug 8, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT EVENTS. THIS IS THE SECOND OF TEN REPORTS. REFER TO 8030647-2022-00173 FOR THE FIRST EVENT. REFER TO 8030647-2022-00175 FOR THE THIRD EVENT. REFER TO 8030647-2022-00176 FOR THE FOURTH EVENT. REFER TO 8030647-2022-00177 FOR THE FIFTH EVENT. REFER TO 8030647-2022-00178 FOR THE SIXTH EVENT. REFER TO 8030647-2022-00179 FOR THE SEVENTH EVENT. REFER TO 8030647-2022-00180 FOR THE EIGHTH EVENT. REFER TO 8030647-2022-00181 FOR THE NINTH EVENT. REFER TO 8030647-2022-00182 FOR THE TENTH EVENT. IT WAS REPORTED THE SUCTION CATHETER WAS UNABLE TO SUCTION ANYTHING, EVEN WATER WAS TRIED BY CAREGIVER. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15189413 ↗
• MalfunctionAug 8, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT EVENTS. THIS IS THE THIRD OF TEN REPORTS. REFER TO 8030647-2022-00173 FOR THE FIRST EVENT. REFER TO 8030647-2022-00174 FOR THE SECOND EVENT. REFER TO 8030647-2022-00176 FOR THE FOURTH EVENT. REFER TO 8030647-2022-00177 FOR THE FIFTH EVENT. REFER TO 8030647-2022-00178 FOR THE SIXTH EVENT. REFER TO 8030647-2022-00179 FOR THE SEVENTH EVENT. REFER TO 8030647-2022-00180 FOR THE EIGHTH EVENT. REFER TO 8030647-2022-00181 FOR THE NINTH EVENT. REFER TO 8030647-2022-00182 FOR THE TENTH EVENT. IT WAS REPORTED THE SUCTION CATHETER WAS UNABLE TO SUCTION ANYTHING, EVEN WATER WAS TRIED BY CAREGIVER. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15189412 ↗
• MalfunctionAug 8, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT EVENTS. THIS IS THE FIRST OF TEN REPORTS. REFER TO 8030647-2022-00174 FOR THE SECOND EVENT. REFER TO 8030647-2022-00175 FOR THE THIRD EVENT. REFER TO 8030647-2022-00176 FOR THE FOURTH EVENT. REFER TO 8030647-2022-00177 FOR THE FIFTH EVENT. REFER TO 8030647-2022-00178 FOR THE SIXTH EVENT. REFER TO 8030647-2022-00179 FOR THE SEVENTH EVENT. REFER TO 8030647-2022-00180 FOR THE EIGHTH EVENT. REFER TO 8030647-2022-00181 FOR THE NINTH EVENT. REFER TO 8030647-2022-00182 FOR THE TENTH EVENT. IT WAS REPORTED THE SUCTION CATHETER WAS UNABLE TO SUCTION ANYTHING, EVEN WATER WAS TRIED BY CAREGIVER. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15189411 ↗
• MalfunctionJun 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030647-2022-00152 FOR THE SECOND REPORT. REFER TO 8030647-2022-00153 FOR THE THIRD REPORT. 3 CIRCUIT LEAKS WERE REPORTED, THERE WAS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 19MAY2022 REPORTED THAT THE LEAK OCCURRED WHILE THE THUMB VALVE WAS IN THE LOCKED POSITION; IT WAS NOT DEPRESSED AND NOT OPENED; ADDITIONALLY, POSSIBLE MINOR DESATURATION AND VENTILATOR ALARMING WAS NOTED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: Low Oxygen Saturation

  MAUDE report 14607614 ↗
• MalfunctionJun 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 8030647-2022-00151 FOR THE FIRST REPORT. REFER TO 8030647-2022-00153 FOR THE THIRD REPORT. 3 CIRCUIT LEAKS WERE REPORTED, THERE WAS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 19MAY2022 REPORTED THAT THE LEAK OCCURRED WHILE THE THUMB VALVE WAS IN THE LOCKED POSITION; IT WAS NOT DEPRESSED AND NOT OPENED; ADDITIONALLY, POSSIBLE MINOR DESATURATION AND VENTILATOR ALARMING WAS NOTED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: Low Oxygen Saturation

  MAUDE report 14607515 ↗
• MalfunctionJun 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2022-00151 FOR THE FIRST REPORT. REFER TO 8030647-2022-00152 FOR THE SECOND REPORT. 3 CIRCUIT LEAKS WERE REPORTED, THERE WAS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 19MAY2022 REPORTED THAT THE LEAK OCCURRED WHILE THE THUMB VALVE WAS IN THE LOCKED POSITION; IT WAS NOT DEPRESSED AND NOT OPENED; ADDITIONALLY, POSSIBLE MINOR DESATURATION AND VENTILATOR ALARMING WAS NOTED. THERE WAS NO REPORT OF PATIENT HARM

  Patient problems: Low Oxygen Saturation

  MAUDE report 14607448 ↗
• MalfunctionApr 21, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030647-2022-00123 FOR THE SECOND EVENT. REFER TO 8030647-2022-00124 FOR THE THIRD EVENT. IT WAS REPORTED THE DEVICES WERE NOT SUCTIONING DURING PATIENT USE.

  Patient problems: Insufficient Information

  MAUDE report 14173109 ↗
• MalfunctionApr 21, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE INLINE SUCTION CAP WAS STUCK, CREATING A LARGE LEAK DURING MECHANICAL VENTILATION. THE PATIENT WAS UNABLE TO GET ADEQUATE VOLUME AND WAS EXPERIENCING OXYGEN DESATURATION. THERE WAS NO REPORTED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 14173049 ↗
• MalfunctionApr 21, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE ETCO2 [END-TIDAL CARBON DIOXIDE] WAS READING LOW AS WELL AS EXHALED VOLUME. THE PATIENT'S BREATH SOUNDS WERE CLEAR AND BILATERALLY WITH NO AUDIBLE LEAK HEARD. THE PATENT'S TRACH CUFF WAS DEFLATED AND REINFLATED. DISPLAY ON ETCO2 SHOWED A MUCH LOWER RR [RESPIRATORY RATE] THAN THE PATIENT'S ACTUAL RR SO ALL END TIDAL DISPOSABLE EQUIPMENT WAS REPLACED, AND A NEW MODULE WAS USED WITH NO CHANGE IN ETCO2 OR RR READING. NO AUDIBLE LEAK WAS NOTED, AND THE IN-LINE SUCTION CATHETER WAS ABLE TO PASS AND FUNCTIONED. THE PATIENT WAS MUCH LESS AROUSABLE THAN USUAL. AN I-STAT [BLOOD ANALYSIS TEST] WAS PERFORMED USING VENOUS BLOOD SHOWING NORMAL VALUES. THE VENTILATOR WAS THEN CHANGED TO A V500 MACHINE AND PROBLEM OF HIGH LEAK PERSISTED. THE TRACHEOSTOMY WAS THEN CHANGED TO RULE OUT AIRWAY DISLODGEMENT TO NO AVAIL. THE ONLY PART OF THE PATIENT VENTILATOR CIRCUIT THAT WAS NOT REPLACED YET WAS THE IN-LINE SUCTION CATHETER AND AFTER DOING THAT IT WAS NOTICED THAT THE SUCTION BUTTON DID NOT FULLY SPRING BACK TO COMPLETELY OFF LEAVING A CONTINUOUS SUCTION TO THE AIRWAY.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 14173041 ↗
• MalfunctionApr 21, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 8030647-2022-00122 FOR THE FIRST EVENT. REFER TO 8030647-2022-00124 FOR THE THIRD EVENT. IT WAS REPORTED THE DEVICES WERE NOT SUCTIONING DURING PATIENT USE.

  Patient problems: Insufficient Information

  MAUDE report 14173038 ↗
• MalfunctionApr 21, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE CLOSED SUCTION CATHETER CAUSED THE VENTILATOR TO READ "100% LEAK WHEN OPEN." ONCE THE SUCTION CATHETER WAS CLOSED AND LOCKED THE "VENTILATOR READ 0% LEAK." THE DEVICE WAS REPLACED FOR ANOTHER DEVICE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14172999 ↗
• MalfunctionApr 21, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE CLOSED SUCTION CATHETER "SUCTION BUTTON GOT STUCK WHILE TRYING TO SUCTION CAUSING LEAK." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14172994 ↗