Puritan Bennett 980S1ENDICURecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521171114), received between Sep 2, 2020 and Jan 10, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “No Flow” (4 reports).

3 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Mar 25, 2022Class IOpen, Classified

   The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.

   Z-0966-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Nov 4, 2021Class ITerminated

   Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

   Z-0340-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

3. Oct 16, 2020Class IIOpen, Classified

   In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm,

   Z-0425-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR GENERATED A ¿VENTILATOR INOPERATIVE¿ MESSAGE AND DIAGNOSTIC CODE INDICATING BACKUP VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132221 ↗
• MalfunctionJul 26, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE INITIATING THE PATIENT ON BIPAP (BILEVEL POSITIVE AIRWAY PRESSURE) APPROXIMATELY 3 MINUTES ELAPSED AND THIS 980 VENTILATOR ENTERED INTO BACKUP VENTILATION WITH A CONSTANT HIGH EMERGENCY ALARM THAT COULD NOT BE SILENCED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15104795 ↗
• MalfunctionMar 31, 2021No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A POST CARDIAC SURGICAL PATIENT, THIS 980 VENTILATOR SPONTANEOUS SHUT OFF WITHOUT WARNING. AFTER ABOUT ONE MINUTE THE VENTILATOR REBOOTED ITSELF. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11596009 ↗
• MalfunctionJan 26, 2021No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR ¿TURNED OFF¿. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM OR INJURY. BASED ON THE REVIEW OF THE VENTILATOR LOGS, A LOSS OF VENTILATION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11230483 ↗
• MalfunctionDec 15, 2020No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR GENERATED A HIGH PRIORITY ALARM THAT COULD NOT BE SILENCED OR RESET AND A SAFETY VALVE OPEN ALERT CONDITION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11012905 ↗
• MalfunctionSep 2, 2020Infusion or Flow Problem; No Flow; Infusion or Flow Problem; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, IN A NON-INVASIVE MODE, THIS 980 VENTILATOR WAS NOT VENTILATING AND GENERATED THE FOLLOWING MESSAGES, "VENT INOP (VENTILATOR INOPERATIVE), NO O2 (OXYGEN) SUPPLY, NO AIR SUPPLY". THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10485606 ↗