Puritan Bennett 980X3ENDIUU-RMFRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884521592926), received between Oct 7, 2019 and Jun 30, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (19 reports).

1 FDA recall record name this device's identifier, 1 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR DISPLAYED A BACKGROUND FAULT DIAGNOSTIC CODE INDICATING THE VENTILATOR ENTERED INTO BACK UP 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 25669423 ↗
• MalfunctionMar 31, 2026Defective Alarm; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR DID NOT PASS THE POWER CAPACITOR BREATH DELIVERY (BD) AUDIO TEST PORTION OF THE EXTENDED SELF TEST (EST). 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 24746240 ↗
• MalfunctionAug 14, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR DID NOT PASS THE CIRCUIT PRESSURE TEST OF THE EXTENDED SELF TEST (EST) WITH AN INSPIRATORY AUTO ZERO SOLENOID NOT OPERATIONAL MESSAGE. 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 22805135 ↗
• MalfunctionApr 3, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR GENERATED A POWER ON SELF TEST (POST) DIAGNOSTIC CODE. 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 21763341 ↗
• MalfunctionSep 19, 2024Improper Flow or Infusion; Pressure Problem; Improper Flow or Infusion; Pressure Problem

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR HAD A COMPRESSOR FAULT AND DISPLAYED A "COMPRESSOR 24 VOLT (V) POWER OUT OF RANGE (OOR)" MESSAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20261979 ↗
• MalfunctionSep 5, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR GENERATED A BACK UP VENTILATION (BUV) BACKGROUND FAULT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY. THE BIOMEDICAL ENGINEER THEN REPORTED THE VENTILATOR FAILED THE EXTENDED SELF TEST (EST) AFTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20150302 ↗
• MalfunctionJan 18, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR SHUT DOWN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. ALTHOUGH IT WAS REPORTED THAT THE VENTILATOR SHUTDOWN, THE ERROR CODE PROVIDED INDICATED THAT THE DEVICE ENTERED INTO BACKUP VENTILATION (BUV)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18538081 ↗
• MalfunctionDec 5, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING A FIELD ACTION SOFTWARE UPDATE, THIS 980 VENTILATOR FAILED THE EXTENDED SELF TEST (EST) WITH AN "INSPIRATORY AUTO ZERO SOLENOID NOT OPERATIONAL" MESSAGE. 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 18267871 ↗
• MalfunctionDec 1, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR "SHUT DOWN". THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY. ALTHOUGH IT WAS REPORTED THAT THE VENTILATOR "SHUT DOWN", A REVIEW OF THE DIAGNOSTIC CODE PROVIDED INDICATES THE VENTILATOR ENTERED INTO BACKUP VENTILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248670 ↗
• MalfunctionOct 19, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT AFTER A FIELD ACTION, THIS 980 VENTILATOR FAILED THE CIRCUIT PRESSURE PORTION OF THE EXTENDED SELF TEST (EST). 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 17968103 ↗
• MalfunctionSep 8, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR SHUT DOWN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. ALTHOUGH IT WAS REPORTED THAT THE VENTILATOR SHUTDOWN, THE ERROR CODE PROVIDED INDICATED THAT THE DEVICE ENTERED INTO BACKUP VENTILATION (BUV).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715522 ↗
• MalfunctionDec 13, 2022Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR POWER ON SELF TEST (POST) FAILED. 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 15971305 ↗
• MalfunctionDec 9, 2022Date/Time-Related Software Problem; Improper Flow or Infusion; Date/Time-Related Software Problem; Improper Flow or Infusion

  IT WAS REPORTED THAT THE 980 VENTILATOR FAILED TO ADMINISTER THE CORRECT DATE AND TIME, WHICH PREVENTED RUNNING TESTS AND PERFORMING CALIBRATION. 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 15952442 ↗
• MalfunctionJun 3, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING USE ON A PATIENT THIS 980 VENTILATOR SHUT OFF AND STOPPED DELIVERING BREATHS. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. A REVIEW OF THE REPAIR DETAILS AND DIAGNOSTIC LOGS INDICATE THE DEVICE ENTERED BACKUP VENTILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14593986 ↗
• MalfunctionMar 28, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR "FAILED ON PATIENT" AND GENERATED A "VENTILATOR INOPERATIVE¿ MESSAGE. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY. A REVIEW OF THE DIAGNOSTIC LOGS INDICATES THE DEVICE ENTERED BACKUP VENTILATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929845 ↗
• MalfunctionDec 10, 2021No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR STOPPED VENTILATING AND WAS INOPERATIVE. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY. A REVIEW OF THE LOGS INDICATES THERE WAS A LOSS OF VENTILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12976457 ↗
• MalfunctionSep 14, 2021No Flow; No Flow

  IT WAS REPORTED THAT, DURING USE ON A PATIENT, THIS 980 VENTILATOR STOPPED VENTILATION. 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 12467253 ↗
• MalfunctionAug 23, 2021No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR STOPPED VENTILATING. 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 12354393 ↗
• MalfunctionFeb 23, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 980 VENTILATOR DISPLAYED A "MIX BACKUP VENTILATION (BUV)" BREATH DELIVERY (BD) B ACKGROUND FAULT. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369330 ↗
• MalfunctionOct 29, 2020Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 980 VENTILATOR GENERATED A "VENT INOP" ALARM AND ENTERED BACKUP VENTILATION. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR AND THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT.

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

  MAUDE report 10757005 ↗
• MalfunctionOct 27, 2020No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT A 980 VENTILATOR GENERATED A ¿VOLTAGE OUT OF RANGE (OOR)" ERROR MESSAGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10741127 ↗
• MalfunctionOct 13, 2020Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 980 VENTILATOR SHUT DOWN AND GENERATED A MIX SUBSYSTEM ERROR. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR AND THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT. PER REVIEW OF THE LOGS, THE 980 VENTILATOR ENTERED BACK UP VENTILATION AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10674216 ↗
• MalfunctionSep 10, 2020Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR ENTERED INTO BACK UP VENTILATION (BUV). THE 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 10516446 ↗
• MalfunctionJun 10, 2020Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR WENT ¿VENTILATOR INOPERATIVE¿. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138016 ↗
• MalfunctionMay 27, 2020Smoking; No Flow; Smoking; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR SHUT OFF, STOPPED DELIVERING BREATHS WITH A BURNT SMELL AND SMOKE. 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; No Consequences Or Impact To Patient

  MAUDE report 10093992 ↗