Puritan Bennett G-061949-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521180970), received between Feb 21, 2018 and Aug 23, 2021 — classified as 18 malfunctions.

The most frequently reported specific device problem is “No Flow” (9 reports).

4 other recalls cover devices cleared under the same FDA submission (K984379); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2021No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT THE 760 VENTILATOR GENERATED A VENT INOPERATIVE ERROR AND WOULD NOT ALLOW SHORT SELF-TEST (SST). THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353708 ↗
• MalfunctionJul 9, 2021No Flow; Power Problem; No Flow; Power Problem

  IT WAS REPORTED THAT THE 760 VENTILATOR WOULD NOT POWER UP. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED E VENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144421 ↗
• MalfunctionJun 16, 2021No Flow; Power Problem; No Flow; Power Problem

  IT WAS REPORTED THAT THE 760 VENTILATOR WOULD NOT POWER UP. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED E VENT. IT WAS NOTED THAT DURING EVALUATION OF THE DEVICE ,FOUND A FAULT THAT COULD LEAD TO A LOSS OF VENTILATION IF THE FAULT WERE TO OCCUR WHILE IN USE ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12013599 ↗
• MalfunctionAug 25, 2020No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE 760 VENTILATOR STOPPED VENTILATING AND SHUT DOWN. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE VENTILATOR WITHOUT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10448056 ↗
• MalfunctionDec 9, 2019Infusion or Flow Problem; No Flow; Infusion or Flow Problem; No Flow

  IT WAS REPORTED THAT THE 760 VENTILATOR FAILED OXYGEN FLOW. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED E VENT.

  Patient problems: No Patient Involvement

  MAUDE report 9438470 ↗
• MalfunctionSep 9, 2019No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT THE 760 VENTILATOR BECAME INOPERATIVE WITH AUDIBLE AND VISUAL ALARM AND STOPPED VENTILATION. IT WAS ALSO NOTED THAT VENTILATOR FAILED POST (POWER ON SELF-TEST) AFTER POWER CYCLING AND HAS DIAGNOSTIC ERROR CODES PRESENT IN THE LOGS. PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8976110 ↗
• MalfunctionJan 7, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE 700 SERIES VENTILATOR FAILED POST (POWER ON SELF TEST) WITH AN ERROR CODE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8224677 ↗
• MalfunctionDec 21, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE 760 VENTILATOR HAD FAILED POST (POWER ON SELF TEST) AND ADDITIONALLY EST (EXTENDED SELF TEST) FAILURE OCCURRED BECAUSE OF FAULTY AIR INTAKE ASSEMBLY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8192056 ↗
• MalfunctionNov 27, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT THE 760 VENTILATOR HAD FAILED SST(SHORT SELF-TEST). THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8108730 ↗
• MalfunctionNov 16, 2018No Flow; No Flow

  IT WAS REPORTED THAT THE 740 VENTILATOR FAILED THE POWER ON SELF TEST (POST). THERE WAS NO PATIENT INVOLVEMENT WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8081812 ↗
• MalfunctionOct 19, 2018No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON PATIENT THE 760 VENTILATOR APPEARS TO HAVE RUN A BACKGROUND CHECK THAT GENERATED BOTH A CONSTANT AUDIO AND VISUAL ALARM. THE VENTILATOR STOPPED DELIVERING BREATHS TO THE PATIENT AND SAFETY VALVE OPENED. THE VENTILATOR WENT INOPERATIVE AND ALSO DISPLAYED POST T DEL (POWER ON SELF TEST) (DELIVERED TIDAL VOLUME) ERROR MESSAGES. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM OR INJURY.

  Patient problems: No Code Available

  MAUDE report 7987496 ↗
• MalfunctionAug 13, 2018Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT DURING USE ON PATIENT THE 700 SERIES VENTILATOR HAS ABNORMAL RESTART (INOPERATIVE). PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED.

  Patient problems: No Code Available

  MAUDE report 7779095 ↗
• MalfunctionJul 31, 2018No Flow; Appropriate Device Problem Term/Code Not Available; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT THE 700 SERIES VENTILATOR SAFETY VALVE OPENED. PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7736529 ↗
• MalfunctionJul 3, 2018Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE VENTILATOR BECAME INOPERATIVE. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THERE WAS NO ADVERSE EVENT OR CONSEQUENCES AS A RESULT.

  Patient problems: No Code Available

  MAUDE report 7659563 ↗
• MalfunctionJun 8, 2018Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT THE VENTILATOR SHUT DOWN DURING USE ON A PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THERE WAS NO ADVERSE EVENT OR CONSEQUENCE AS RESULT OF THE REPORTED EVENT.

  Patient problems: No Code Available

  MAUDE report 7582512 ↗
• MalfunctionJun 7, 2018Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT DURING USE ON A PATIENT THE 760 VENTILATOR STOPPED VENTILATION TO THE PATIENT. PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED.

  Patient problems: No Code Available

  MAUDE report 7580872 ↗
• MalfunctionMay 17, 2018Device Inoperable; Incorrect Error Code; Device Inoperable; Incorrect Error Code

  IT WAS REPORTED THAT DURING USE ON A PATIENT THE 700 SERIES VENTILATOR WAS INOPERATIVE. THERE WAS NO FURTHER DETAILS AVAILABLE. ALTHOUGH REQUESTED THAT IT IS UNKNOWN REGARDING THE PATIENT TRANSFER AND ANY HARM REPORTED.

  Patient problems: No Code Available

  MAUDE report 7524470 ↗
• MalfunctionFeb 21, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE VENTILATOR DID NOT PASS POWER ON SELF TESTS. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER REPLACED THE NON VOLATILE RANDOM ACCESS MEMORY (NVRAM). THE VENTILATOR PASSED SELF-TESTING.

  Patient problems: No Patient Involvement

  MAUDE report 7287721 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K984379. One submission often covers many models, so check the product and lot details in each record.

• Z-0822-2014 · Jan 25, 2013 · Terminated
  Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use
• Z-0821-2014 · Jan 25, 2013 · Terminated
  Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivere
• Z-0445-05 · Dec 17, 2004 · Terminated
  Model 740 and 760 series Ventilators.
• Z-0444-05 · Dec 16, 2004 · Terminated
  Internal Battery for Puritan Bennett 700 Series Ventilator.