Halyard 13221Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10680651132212), received between Jan 11, 2017 and May 4, 2022 — classified as 1 death, 63 malfunctions.

The most frequently reported specific device problem is “Disconnection” (29 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2022Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT "THE TUBE ON THE CUFF INFLATOR HAS BEEN BITTEN, THEY THINK, AND THE DR COULD SEE THE AIR ESCAPING WHEN THEY PLACED IT UNDER WATER." THERE WAS NO INJURY TO THE PATIENT. THE DEVICE HAD ONLY BEEN IN USE FOR A FEW MINUTES. THE PATIENT WAS RE-SEDATED, RE-INTUBATED, AND X-RAYED FOR THE POSITION OF THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274547 ↗
• MalfunctionApr 25, 2022Inflation Problem; Inflation Problem

  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 9611594-2022-00051FOR THE FIRST REPORT. REFER TO 9611594-2022-00052 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE CUFF DID NOT INFLATE COMPLETELY AND WAS NOT STABLE IN THE PATIENT, IT WAS ADDITIONALLY REPORTED THAT THERE WAS WATER IN THE BALLOON. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197533 ↗
• MalfunctionApr 25, 2022Inflation Problem; Inflation Problem

  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 9611594-2022-00052 FOR THE SECOND REPORT. REFER TO 9611594-2022-00053 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE CUFF DID NOT INFLATE COMPLETELY AND WAS NOT STABLE IN THE PATIENT, IT WAS ADDITIONALLY REPORTED THAT THERE WAS WATER IN THE BALLOON. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197532 ↗
• MalfunctionApr 25, 2022Inflation Problem; Inflation Problem

  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 9611594-2022-00051 FOR THE FIRST REPORT. REFER TO 9611594-2022-00053 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE CUFF DID NOT INFLATE COMPLETELY AND WAS NOT STABLE IN THE PATIENT, IT WAS ADDITIONALLY REPORTED THAT THERE WAS WATER IN THE BALLOON. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197531 ↗
• MalfunctionMar 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE IRRIGATION PORT BROKE AFTER 2 WEEKS OF USE. THE ENDOTRACHEAL TUBE WAS REPLACED FOR A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13765233 ↗
• MalfunctionFeb 8, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THE CUFF WOULD NOT INFLATE DURING USE. THE PATIENT WAS EXTUBATED AND THE DEVICE WAS REPLACED FOR A NEW ONE. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13486671 ↗
• MalfunctionOct 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PILOT BALLOON CAME DETACHED FROM THE INFLATION TUBE. THE ENDOTRACHEAL TUBE (ETT) WAS REPLACED FOR A NEW ONE. THERE WAS NO INJURY TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10751657 ↗
• MalfunctionMay 28, 2020Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2020-00086 FOR THE FIRST REPORT. REFER TO 9611594-2020-00087 FOR THE SECOND REPORT. FDA MEDWATCH / FDA USER FACILITY REPORT #MW5094284 WAS RECEIVED ON 07-MAY-2020. THE FOLLOWING INFORMATION WAS PROVIDED: "PATIENT WAS INTUBATED USING A 7.5 HILO VAC ENDOTRACHEAL TUBE, ONCE INTUBATED, THE CUFF OF THE ENDOTRACHEAL TUBE WOULD NOT INFLATE. HAD TO EXTUBATE AND RE INTUBATE ALREADY HYPOXIC PATIENT." ADDITIONAL INFORMATION RECEIVED 20-MAY-2020 INDICATED THE PRODUCT WAS NOT ALTERED IN ANY WAY PRIOR TO USE. THE PROBLEM WAS DISCOVERED WHEN THE "PATIENT FAILING TO VENTILATE DUE TO MUCOUS PLUG, ELECTIVELY RE-INTUBATED. 3 FAILED IN SEQUENCE (CUFF WOULD NOT REMAIN INFLATED) RESULTED IN SEVERAL INTUBATION MANEUVERS BY INTENSIVIST MD UNTIL DIFFERENT BOX WAS OBTAINED." RESOLVED BY REINTUBATION BY PROVIDER FROM A NEW LOT.

  Patient problems: Hypoxia

  MAUDE report 10097271 ↗
• MalfunctionMay 28, 2020Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2020-00086 FOR THE FIRST REPORT. REFER TO 9611594-2020-00088 FOR THE THIRD REPORT. FDA MEDWATCH / FDA USER FACILITY REPORT #MW5094284 WAS RECEIVED ON 07-MAY-2020. THE FOLLOWING INFORMATION WAS PROVIDED: "PATIENT WAS INTUBATED USING A 7.5 HILO VAC ENDOTRACHEAL TUBE, ONCE INTUBATED, THE CUFF OF THE ENDOTRACHEAL TUBE WOULD NOT INFLATE. HAD TO EXTUBATE AND RE INTUBATE ALREADY HYPOXIC PATIENT." ADDITIONAL INFORMATION RECEIVED 20-MAY-2020 INDICATED THE PRODUCT WAS NOT ALTERED IN ANY WAY PRIOR TO USE. THE PROBLEM WAS DISCOVERED WHEN THE "PATIENT FAILING TO VENTILATE DUE TO MUCOUS PLUG, ELECTIVELY RE-INTUBATED. 3 FAILED IN SEQUENCE (CUFF WOULD NOT REMAIN INFLATED) RESULTED IN SEVERAL INTUBATION MANEUVERS BY INTENSIVIST MD UNTIL DIFFERENT BOX WAS OBTAINED." RESOLVED BY REINTUBATION BY PROVIDER FROM A NEW LOT.

  Patient problems: Hypoxia

  MAUDE report 10097266 ↗
• MalfunctionMay 28, 2020Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2020-00087 FOR THE SECOND REPORT. REFER TO 9611594-2020-00088 FOR THE THIRD REPORT. FDA MEDWATCH / FDA USER FACILITY REPORT #MW5094284 WAS RECEIVED ON 07-MAY-2020. THE FOLLOWING INFORMATION WAS PROVIDED: "PATIENT WAS INTUBATED USING A 7.5 HILO VAC ENDOTRACHEAL TUBE, ONCE INTUBATED, THE CUFF OF THE ENDOTRACHEAL TUBE WOULD NOT INFLATE. HAD TO EXTUBATE AND RE INTUBATE ALREADY HYPOXIC PATIENT." ADDITIONAL INFORMATION RECEIVED 20-MAY-2020 INDICATED THE PRODUCT WAS NOT ALTERED IN ANY WAY PRIOR TO USE. THE PROBLEM WAS DISCOVERED WHEN THE "PATIENT FAILING TO VENTILATE DUE TO MUCOUS PLUG, ELECTIVELY RE-INTUBATED. 3 FAILED IN SEQUENCE (CUFF WOULD NOT REMAIN INFLATED) RESULTED IN SEVERAL INTUBATION MANEUVERS BY INTENSIVIST MD UNTIL DIFFERENT BOX WAS OBTAINED." RESOLVED BY REINTUBATION BY PROVIDER FROM A NEW LOT.

  Patient problems: Hypoxia

  MAUDE report 10097259 ↗
• MalfunctionSep 6, 2019Disconnection; Disconnection

  IT WAS REPORTED THE VENT ADAPTOR POPPED OFF DURING USE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8970723 ↗
• MalfunctionAug 13, 2019Disconnection; Disconnection

  PER ADDITIONAL INFORMATION RECEIVED 13 AUG 2019, THE STAFF BECAME AWARE OF THE ISSUE BY THE VENT ALARM SOUNDING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8891222 ↗
• MalfunctionJul 5, 2019Disconnection; Disconnection

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 9611594-2019-00126 FOR THE FIRST EVENT. REFER TO 9611594-2019-00127 FOR THE SECOND EVENT. REFER TO 9611594-2019-00128 FOR THE THIRD EVENT. THE ADAPTER ON THE ENDOTRACHEAL TUBE (ETT) ADAPTER POPPED DURING USE. SOMETIMES THIS OCCURRED WITHIN 20-MINUTES OF THE ETT BEING PLACED. THE RESPIRATORY THERAPISTS WERE TAPING THE ADAPTERS IN PLACE TO PREVENT "POP OFF". THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764395 ↗
• MalfunctionJul 5, 2019Disconnection; Disconnection

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 9611594-2019-00126 FOR THE FIRST EVENT. REFER TO 9611594-2019-00128 FOR THE THIRD EVENT. REFER TO 9611594-2019-00129 FOR THE FOURTH EVENT. THE ADAPTER ON THE ENDOTRACHEAL TUBE (ETT) ADAPTER POPPED DURING USE. SOMETIMES THIS OCCURRED WITHIN 20-MINUTES OF THE ETT BEING PLACED. THE RESPIRATORY THERAPISTS WERE TAPING THE ADAPTERS IN PLACE TO PREVENT "POP OFF." THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764392 ↗
• MalfunctionJul 5, 2019Disconnection; Disconnection

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 9611594-2019-00126 FOR THE FIRST EVENT. REFER TO 9611594-2019-00127 FOR THE SECOND EVENT. REFER TO 9611594-2019-00129 FOR THE FOURTH EVENT. THE ADAPTER ON THE ENDOTRACHEAL TUBE (ETT) ADAPTER POPPED DURING USE. SOMETIMES THIS OCCURRED WITHIN 20-MINUTES OF THE ETT BEING PLACED. THE RESPIRATORY THERAPISTS WERE TAPING THE ADAPTERS IN PLACE TO PREVENT "POP OFF." THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764391 ↗
• MalfunctionJul 5, 2019Disconnection; Disconnection

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 9611594-2019-00127 FOR THE SECOND EVENT. REFER TO 9611594-2019-00128 FOR THE THIRD EVENT. REFER TO 9611594-2019-00129 FOR THE FOURTH EVENT. THE ADAPTER ON THE ENDOTRACHEAL TUBE (ETT) ADAPTER POPPED DURING USE. SOMETIMES THIS OCCURRED WITHIN 20-MINUTES OF THE ETT BEING PLACED. THE RESPIRATORY THERAPISTS WERE TAPING THE ADAPTERS IN PLACE TO PREVENT "POP OFF." THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764385 ↗
• MalfunctionJun 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE CUSTOMER EXPRESSED A CONCERN REGARDING THE LOOSENING OF THE BLUE CONNECTORS ON THE SUBGLOTTIC SUCTIONING MICROCUFF (SSM). THIS LOOSENING OCCURS OVER TIME WHILE THE TUBE IS IN USE. THE CONNECTOR THEN RANDOMLY FALLS OFF THE BODY OF THE SSM ET [ENDOTRACHEAL] TUBE. THIS IS CONCERNING BECAUSE IT HAS A NEGATIVE IMPACT ON PATIENTS RECEIVING HIGH FI02 [FRACTION OF INSPIRED OXYGEN] AND OR HIGH PEEP [POSITIVE END-EXPIRATORY PRESSURE] DUE TO THE RANDOM DISCONNECTION CONCERN. [THE USER FACILITY HAS] TRIED USING ZIP TIES TO SECURE THE BLUE CONNECTOR WITHOUT SUCCESS. THEY ALSO PRESS FIT THE BLUE CONNECTOR SNUGGLY ONTO THE ET TUBE PRIOR TO INTUBATION AND THIS ISNT CORRECTING THE CONCERN." NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8743505 ↗
• MalfunctionMay 21, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE "ETT [ENDOTRACHEAL TUBE] CONNECTOR POPPED OFF FROM PATIENT WITH RT [RESPIRATORY THERAPIST] IN ROOM LUCKILY. NO ADVERSE EFFECTS NOTED OR DOCUMENTED. HOWEVER THEY DID TRY GOING TO A LARGER SIZE ADAPTER FROM ANOTHER TUBE AND IT WOULD NOT WORK. THE INTENSIVIST FOUND SOME SUPER GLUE SOMEWHERE AND APPLIED IT. THE TUBE IS STILL FUNCTIONING WITH THE GLUE." NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8627115 ↗
• MalfunctionMay 14, 2019Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2019-00089 FOR THE SECOND REPORT. REFER TO 9611594-2019-00090 FOR THE THIRD REPORT. IT WAS REPORTED THAT "BLUE CONNECTOR POPPED OFF OF THE MICROCUFF SUBGLOTTIC ET TUBE...ONCE UPON INTUBATION...NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8607537 ↗
• MalfunctionMay 14, 2019Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2019-00088 FOR THE FIRST REPORT. REFER TO 9611594-2019-00089 FOR THE SECOND REPORT. IT WAS REPORTED THAT "BLUE CONNECTOR POPPED OFF OF THE MICROCUFF SUBGLOTTIC ET TUBE...DURING USE...NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8607535 ↗
• MalfunctionMay 14, 2019Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2019-00088 FOR THE FIRST REPORT. REFER TO 9611594-2019-00090 FOR THE THIRD REPORT. IT WAS REPORTED THAT "BLUE CONNECTOR POPPED OFF OF THE MICROCUFF SUBGLOTTIC ET TUBE...DURING USE...NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8607532 ↗
• MalfunctionApr 19, 2019Pressure Problem; Pressure Problem

  ACCORDING TO THE REPORT, "TWO PATIENTS HAD TO BE REINTUBATED DUE TO CUFF LEAKAGE. HAPPENED IN THE NIGHT SHIFT. CUSTOMER DIDN¿T KEEP SAMPLES." AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO (2) DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING (2) DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2019-00082 FOR THE SECOND REPORT.

  Patient problems: No Code Available

  MAUDE report 8531232 ↗
• MalfunctionApr 10, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE BLUE CONNECTOR FELL OFF DURING INTUBATION. THE CUSTOMER FELT THAT THE CONNECTOR WAS TOO LOOSELY ATTACHED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8501307 ↗
• MalfunctionApr 5, 2019Disconnection; Disconnection

  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 9611594-2019-00066 FOR THE FIRST EVENT. REFER TO 9611594-2019-00067 FOR THE SECOND EVENT. REFER TO 9611594-2019-00068 FOR THE THIRD EVENT. REFER TO 9611594-2019-00069 FOR THE FOURTH EVENT. REFER TO 9611594-2019-00070 FOR THE FIFTH EVENT. REFER TO 9611594-2019-00071 FOR THE SIXTH EVENT. REFER TO 9611594-2019-00072 FOR THE SEVENTH EVENT. REFER TO 9611594-2019-00074 FOR THE NINTH EVENT. REFER TO 9611594-2019-00075 FOR THE TENTH EVENT. IT WAS REPORTED THE ENDOTRACHEAL TUBE BLUE CONNECTOR WAS COMING OFF EASILY FROM THE TUBE, CREATING A DISCONNECTION ISSUE AND THIS DISCONNECTION ALSO OCCURS WHEN THE TEMPERATURE RISES IN THE RESPIRATORY CIRCUIT. THIS IMPACTS THE VENTILATOR PATIENTS WHO ARE ON VENTILATOR HIGH PRESSURE MODE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8488404 ↗
• MalfunctionApr 5, 2019Disconnection; Disconnection

  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 9611594-2019-00066 FOR THE FIRST EVENT. REFER TO 9611594-2019-00067 FOR THE SECOND EVENT. REFER TO 9611594-2019-00068 FOR THE THIRD EVENT. REFER TO 9611594-2019-00069 FOR THE FOURTH EVENT. REFER TO 9611594-2019-00071 FOR THE SIXTH EVENT. REFER TO 9611594-2019-00072 FOR THE SEVENTH EVENT. REFER TO 9611594-2019-00073 FOR THE EIGHTH EVENT. REFER TO 9611594-2019-00074 FOR THE NINTH EVENT. REFER TO 9611594-2019-00075 FOR THE TENTH EVENT. IT WAS REPORTED THE ENDOTRACHEAL TUBE BLUE CONNECTOR WAS COMING OFF EASILY FROM THE TUBE, CREATING A DISCONNECTION ISSUE AND THIS DISCONNECTION ALSO OCCURS WHEN THE TEMPERATURE RISES IN THE RESPIRATORY CIRCUIT. THIS IMPACTS THE VENTILATOR PATIENTS WHO ARE ON VENTILATOR HIGH PRESSURE MODE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8488401 ↗