AVANOS 13221Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00609038132211), received between Jun 11, 2020 and Nov 23, 2021 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2021Material Rupture; Material Rupture

  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 THIRD OF THREE REPORTS. REFER TO 9611594-2021-00169 FOR THE FIRST EVENT. REFER TO 9611594-2021-00170 FOR THE SECOND EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865223 ↗
• MalfunctionNov 23, 2021Material Rupture; Material Rupture

  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 9611594-2021-00170 FOR THE SECOND EVENT. REFER TO 9611594-2021-00171 FOR THE THIRD EVENT. IT WAS REPORTED THE ENDOTRACHEAL TUBE (ETT) CUFF BURST. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865217 ↗
• MalfunctionNov 23, 2021Material Rupture; Material Rupture

  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 9611594-2021-00169 FOR THE FIRST EVENT. REFER TO 9611594-2021-00171 FOR THE THIRD EVENT. IT WAS REPORTED THE ENDOTRACHEAL TUBE (ETT) CUFF BURST. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865209 ↗
• MalfunctionNov 22, 2021Gas/Air Leak; Gas/Air Leak

  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 9611594-2021-00166 FOR THE FIRST EVENT. REFER TO 9611594-2021-00168 FOR THE THIRD EVENT. IT WAS REPORTED THE ENDOTRACHEAL TUBE (ETT) PILOT BALLOON WAS NOT HOLDING AIR. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857798 ↗
• MalfunctionNov 22, 2021Gas/Air Leak; Gas/Air Leak

  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 THIRD OF THREE REPORTS. REFER TO 9611594-2021-00166 FOR THE FIRST EVENT. REFER TO 9611594-2021-00167 FOR THE SECOND EVENT. IT WAS REPORTED THE ENDOTRACHEAL TUBE (ETT) PILOT BALLOON WAS NOT HOLDING AIR. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857786 ↗
• MalfunctionNov 22, 2021Gas/Air Leak; Gas/Air Leak

  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 9611594-2021-00167 FOR THE SECOND EVENT. REFER TO 9611594-2021-00168 FOR THE THIRD EVENT. IT WAS REPORTED THE ENDOTRACHEAL TUBE (ETT) PILOT BALLOON WAS NOT HOLDING AIR. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857746 ↗
• MalfunctionOct 22, 2021Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2021-00150 FOR THE FIRST EVENT. IT WAS REPORTED THE TUBES WAS "MIGRATING HIGH AND GETTING OVER INFLATED WHILE PRONING." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 30-SEP-2021 STATED, "THERE WERE SOME X-RAYS REVIEWED BY THE CRNA (CERTIFIED REGISTERED NURSE ANESTHETISTS) THAT SHOWED THE TUBE HAD MOVED UP FROM THE CARINA. IT WAS SUGGESTED THAT CUFF INFLATION COULD HAVE BEEN AN ISSUE. THE CUFF PRESSURES WERE NOT CHECKED. THE PATIENT WAS EXTUBATED AND REINTUBATED. THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682789 ↗
• MalfunctionOct 22, 2021Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2021-00151 FOR THE SECOND EVENT. IT WAS REPORTED THE TUBES WAS "MIGRATING HIGH AND GETTING OVER INFLATED WHILE PRONING." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 30-SEP-2021 STATED, "THERE WERE SOME X-RAYS REVIEWED BY THE CRNA (CERTIFIED REGISTERED NURSE ANESTHETISTS) THAT SHOWED THE TUBE HAD MOVED UP FROM THE CARINA. IT WAS SUGGESTED THAT CUFF INFLATION COULD HAVE BEEN AN ISSUE. THE CUFF PRESSURES WERE NOT CHECKED. THE PATIENT WAS EXTUBATED AND REINTUBATED. THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682770 ↗
• MalfunctionJul 8, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE PATIENT "GRABBED HER ENDOTRACHEAL TUBE AND DISLODGED IT AT 0600 IN THE MORNING AND AN ED PHYSICIAN CAME UP TO PUT A NEW ENDOTRACHEAL TUBE IN." THE RESPIRATORY THERAPIST (RT) NOTED THAT AROUND 1115 THE PATIENT WAS NOT KEEPING THEIR VOLUMES ON THE VENTILATOR AND HAD AN AIR LEAK. "THE PHYSICIAN WAS CALLED AND THE [ENDOTRACHEAL TUBE] ETT WAS CHANGED TO AN ETT OF THE SAME SIZE. THE PHYSICIAN AND RT INFLATED THE ETT THEY HAD JUST REMOVED AND FOUND THE BALLOON HAD BROKEN." THE BROKEN ETT BALLOON NEEDED TO BE CHANGED, THE PATIENT REMAINED INTUBATED. THE DEVICE WAS IN USE FOR 5-HOURS. A NEW TUBE WAS CHECKED FOR INTACT BALLOON AND INSERTED; NO LEAK NOTED WITH NEW ETT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 12139645 ↗
• MalfunctionApr 27, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF FAILED TO HOLD ON THE ENDOTRACHEAL TUBE. THE PATIENT WAS REINTUBATED WITHOUT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732070 ↗
• MalfunctionApr 16, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE CLINICIANS HEARD AIR AROUND THE CUFF. THE PATIENT HAD A VERY FORCEFUL COUGH. THE PATIENT REQUIRED REINTUBATION. ADDITIONAL INFORMATION RECEIVED 07-APR-2021 NOTED THE DEVICE WAS NOTED ALTERED IN ANY WAY PRIOR TO USE. THE DEVICE HAD BEEN IN USE FOR ONE TO TWO DAYS WHEN PROBLEM WAS NOTED. THE CUFF WAS FILLED WITH 20CC OF AIR. THE PATIENT'S CURRENT STATUS AS IT RELATES TO THE REPORTED INCIDENT IS "UNKNOWN."

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 11682870 ↗
• MalfunctionApr 16, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE CLINICIANS HEARD AIR AROUND THE CUFF. THE PATIENT HAD A VERY FORCEFUL COUGH. THE PATIENT REQUIRED REINTUBATION. ADDITIONAL INFORMATION RECEIVED 07-APR-2021 NOTED THE DEVICE WAS NOTED ALTERED IN ANY WAY PRIOR TO USE. THE DEVICE HAD BEEN IN USE FOR TWO TO THREE DAYS WHEN PROBLEM WAS NOTED. THE CUFF WAS FILLED WITH 20CC OF AIR. THE ENDOTRACHEAL TUBE (ET TUBE) CURLED UP IN THE PATIENT'S MOUTH, THE PATIENT HAD A VERY FORCEFUL COUGH. THE PATIENT'S CURRENT STATUS AS IT RELATES TO THE REPORTED INCIDENT IS "UNKNOWN."

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 11682794 ↗
• MalfunctionApr 16, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE CLINICIANS HEARD AIR AROUND THE CUFF. THE PATIENT HAD A VERY FORCEFUL COUGH. THE PATIENT REQUIRED REINTUBATION. ADDITIONAL INFORMATION RECEIVED 07-APR-2021 NOTED THE DEVICE WAS NOTED ALTERED IN ANY WAY PRIOR TO USE. THE DEVICE HAD BEEN IN USE FOR TWO DAYS WHEN PROBLEM WAS NOTED. THE CUFF WAS FILLED WITH 20CC OF AIR. THE ENDOTRACHEAL TUBE (ET TUBE) CURLED UP IN THE PATIENT'S MOUTH, THE PATIENT HAD A "SWOLLEN AIRWAY". THE PATIENT'S CURRENT STATUS AS IT RELATES TO THE REPORTED INCIDENT IS "UNKNOWN."

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 11682793 ↗
• MalfunctionFeb 26, 2021Material Rupture; Material Rupture

  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 THIRD OF THREE REPORTS. REFER TO 9611594-2021-00035 FOR THE FIRST EVENT. REFER TO 9611594-2021-00036 FOR THE SECOND EVENT. IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT (B)(4) THE FOLLOWING INFORMATION: INTUBATED PATIENT WITH GLIDES COPE. ENDOTRACHEAL TUBE (ETT) CUFF RUPTURED AFTER INTUBATION. CUFF TESTED ON ANOTHER ETT ONCE INTUBATED, CUFF RUPTURED AGAIN, CUFF TESTED ON ANOTHER ETT AND RUPTURED. ANOTHER ETT OBTAINED WITH SUCCESS ETT CHANGED IT USING TRANSFER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11388484 ↗
• MalfunctionFeb 26, 2021Material Rupture; Material Rupture

  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 9611594-2021-00036 FOR THE SECOND EVENT. REFER TO 9611594-2021-00037 FOR THE THIRD EVENT. IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # (B)(4). THE FOLLOWING INFORMATION: INTUBATED PATIENT WITH GLIDES COPE. ENDOTRACHEAL TUBE (ETT) CUFF RUPTURED AFTER INTUBATION. CUFF TESTED ON ANOTHER ETT ONCE INTUBATED, CUFF RUPTURED AGAIN, CUFF TESTED ON ANOTHER ETT AND RUPTURED. ANOTHER ETT OBTAINED WITH SUCCESS ETT CHANGED IT USING TRANSFER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11388435 ↗
• MalfunctionFeb 26, 2021Material Rupture; Material Rupture

  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 9611594-2021-00035 FOR THE FIRST EVENT. REFER TO 9611594-2021-00037 FOR THE THIRD EVENT. IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT #(B)(4) THE FOLLOWING INFORMATION: INTUBATED PATIENT WITH GLIDES COPE. ENDOTRACHEAL TUBE (ETT) CUFF RUPTURED AFTER INTUBATION. CUFF TESTED ON ANOTHER ETT ONCE INTUBATED, CUFF RUPTURED AGAIN, CUFF TESTED ON ANOTHER ETT AND RUPTURED. ANOTHER ETT OBTAINED WITH SUCCESS ETT CHANGED IT USING TRANSFER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11388402 ↗
• MalfunctionFeb 23, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE "CUFFED ENDOTRACHEAL TUBE WAS USED AND THE CUFF DID NOT INFLATE. PATIENT HAD TO BE REINTUBATED AS A CONSEQUENCE." NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 08-FEB-2021 INDICATED THE PATIENT'S CONDITION IS "STABLE."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11368662 ↗
• MalfunctionNov 24, 2020Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THERE WAS AND INCIDENT OF THE CUFF NOT HOLDING AIR. THE CUFF WAS NOT INFLATING ON INTUBATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10898779 ↗
• MalfunctionNov 18, 2020Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT EVENTS. THIS IS THE SECOND OF EIGHT REPORTS. REFER TO 9611594-2020-00220 FOR THE FIRST EVENT. REFER TO 9611594-2020-00222 FOR THE THIRD EVENT. REFER TO 9611594-2020-00223 FOR THE FOURTH EVENT. REFER TO 9611594-2020-00224 FOR THE FIFTH EVENT. REFER TO 9611594-2020-00225 FOR THE SIXTH EVENT. REFER TO 9611594-2020-00226 FOR THE SEVENTH EVENT. REFER TO 9611594-2020-00227 FOR THE EIGHTH EVENT IT WAS REPORTED THERE WAS AND INCIDENT OF THE CUFF NOT HOLDING AIR. THE CUFF WAS NOT INFLATING ON INTUBATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10861971 ↗
• MalfunctionNov 17, 2020Material Rupture; Material Rupture

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT EVENTS. THIS IS THE SEVENTH OF EIGHT REPORTS. REFER TO 9611594-2020-00220 FOR THE FIRST EVENT. REFER TO 9611594-2020-00221 FOR THE SECOND EVENT. REFER TO 9611594-2020-00222 FOR THE THIRD EVENT. REFER TO 9611594-2020-00223 FOR THE FOURTH EVENT. REFER TO 9611594-2020-00224 FOR THE FIFTH EVENT. REFER TO 9611594-2020-00225 FOR THE SIXTH EVENT. REFER TO 9611594-2020-00227 FOR THE EIGHTH EVENT IT WAS REPORTED THERE WAS AND INCIDENT OF THE CUFF POSSIBLY TEARING AND RUPTURING DURING USE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10857959 ↗
• MalfunctionNov 17, 2020Material Rupture; Material Rupture

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT EVENTS. THIS IS THE EIGHTH OF EIGHT REPORTS. REFER TO 9611594-2020-00220 FOR THE FIRST EVENT. REFER TO 9611594-2020-00221 FOR THE SECOND EVENT. REFER TO 9611594-2020-00222 FOR THE THIRD EVENT. REFER TO 9611594-2020-00223 FOR THE FOURTH EVENT. REFER TO 9611594-2020-00224 FOR THE FIFTH EVENT. REFER TO 9611594-2020-00225 FOR THE SIXTH EVENT. REFER TO 9611594-2020-00226 FOR THE SEVENTH EVENT IT WAS REPORTED THERE WAS AND INCIDENT OF THE CUFF POSSIBLY TEARING AND RUPTURING DURING USE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10857958 ↗
• MalfunctionNov 17, 2020Material Rupture; Material Rupture

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT EVENTS. THIS IS THE FIFTH OF EIGHT REPORTS. REFER TO 9611594-2020-00220 FOR THE FIRST EVENT. REFER TO 9611594-2020-00221 FOR THE SECOND EVENT. REFER TO 9611594-2020-00222 FOR THE THIRD EVENT. REFER TO 9611594-2020-00223 FOR THE FOURTH EVENT. REFER TO 9611594-2020-00225 FOR THE SIXTH EVENT. REFER TO 9611594-2020-00226 FOR THE SEVENTH EVENT. REFER TO 9611594-2020-00227 FOR THE EIGHTH EVENT IT WAS REPORTED THERE WAS AND INCIDENT OF THE CUFF POSSIBLY TEARING AND RUPTURING DURING USE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10857956 ↗
• MalfunctionNov 17, 2020Material Rupture; Material Rupture

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT EVENTS. THIS IS THE SIXTH OF EIGHT REPORTS. REFER TO 9611594-2020-00220 FOR THE FIRST EVENT. REFER TO 9611594-2020-00221 FOR THE SECOND EVENT. REFER TO 9611594-2020-00222 FOR THE THIRD EVENT. REFER TO 9611594-2020-00223 FOR THE FOURTH EVENT. REFER TO 9611594-2020-00224 FOR THE FIFTH EVENT. REFER TO 9611594-2020-00226 FOR THE SEVENTH EVENT. REFER TO 9611594-2020-00227 FOR THE EIGHTH EVENT IT WAS REPORTED THERE WAS AND INCIDENT OF THE CUFF POSSIBLY TEARING AND RUPTURING DURING USE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10857955 ↗
• MalfunctionNov 17, 2020Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT EVENTS. THIS IS THE FOURTH OF EIGHT REPORTS. REFER TO 9611594-2020-00220 FOR THE FIRST EVENT. REFER TO 9611594-2020-00221 FOR THE SECOND EVENT. REFER TO 9611594-2020-00222 FOR THE THIRD EVENT. REFER TO 9611594-2020-00224 FOR THE FIFTH EVENT. REFER TO 9611594-2020-00225 FOR THE SIXTH EVENT. REFER TO 9611594-2020-00226 FOR THE SEVENTH EVENT. REFER TO 9611594-2020-00227 FOR THE EIGHTH EVENT IT WAS REPORTED THERE WAS AND INCIDENT OF THE CUFF NOT HOLDING AIR. THE CUFF WAS NOT INFLATING ON INTUBATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10857954 ↗
• MalfunctionNov 17, 2020Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT EVENTS. THIS IS THE THIRD OF EIGHT REPORTS. REFER TO 9611594-2020-00220 FOR THE FIRST EVENT. REFER TO 9611594-2020-00221 FOR THE SECOND EVENT. REFER TO 9611594-2020-00223 FOR THE FOURTH EVENT. REFER TO 9611594-2020-00224 FOR THE FIFTH EVENT. REFER TO 9611594-2020-00225 FOR THE SIXTH EVENT. REFER TO 9611594-2020-00226 FOR THE SEVENTH EVENT. REFER TO 9611594-2020-00227 FOR THE EIGHTH EVENT IT WAS REPORTED THERE WAS AND INCIDENT OF THE CUFF NOT HOLDING AIR. THE CUFF WAS NOT INFLATING ON INTUBATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10857953 ↗