Puritan Bennett 980X3JADIJJRecalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10884521172531), received between Apr 14, 2017 and Apr 22, 2026 — classified as 1 injury, 69 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (43 reports).

2 FDA recall records 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 ↗

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-0353-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Improper Flow or Infusion; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THESE 980 VENTILATORS ALARMED AND ENTERED INTO BACKUP VENTILATION. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954486 ↗
• MalfunctionFeb 23, 2026No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR SOUNDED AN ALARM AND ¿VENTILATION NOT POSSIBLE¿ WAS DISPLAYED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415552 ↗
• MalfunctionOct 20, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THIS 980 VENTILATOR ALARMED PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23339920 ↗
• MalfunctionSep 12, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED DURING USE ON A PATIENT, THE 980 VENTILATOR ENTERED INTO BACKUP VENTILATION (BUV). THE PATIENT WAS TRANSFERRED TO AN ALTERNATE VENTILATOR WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23044559 ↗
• MalfunctionAug 8, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING SERVICING THIS 980 VENTILATOR FAILED SHORT SELF TEST (SST) WITH AN "INSPIRATORY AUTOZERO 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 22750512 ↗
• MalfunctionMar 12, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING SERVICE THIS 980 VENTILATOR HAD A BACKGROUND FAULT DETECTION OF BACKUP VENTILATION (BUV). 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 21588281 ↗
• MalfunctionFeb 18, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR ALARMED AND DISPLAYED MESSAGE ¿REPLACE DEVICE¿. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21406672 ↗
• MalfunctionFeb 18, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING SERVICE OPERATION CHECK ON A TEST LUNG THESE 980 VENTILATORS SWITCHED TO BACK UP VENTILATION (BUV). 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 21405029 ↗
• MalfunctionJan 21, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR ALARMED AND ENTERED INTO BACK UP VENTILATION (BUV). 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 21203256 ↗
• MalfunctionDec 26, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE THIS 980 VENTILATOR ALARMED AND SWITCHED TO BACK UP VENTILATION (BUV). 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 21020687 ↗
• MalfunctionDec 4, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING SERVICE THIS 980 VENTILATOR FAILED THE EXTENDED SELF TEST (EST) CIRCUIT PRESSURE AUTO ZERO TEST. 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 20843629 ↗
• MalfunctionDec 2, 2024Smoking; Smoking

  IT WAS REPORTED THAT DURING SERVICING, WHEN THIS 980 VENTILATOR WAS POWERED ON, IT EMITTED SMOKE FROM THE BACK OF THE VENTILATOR. 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 20827406 ↗
• MalfunctionNov 13, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING SERVICING, THIS 980 VENTILATOR FAILED THE 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 20677893 ↗
• MalfunctionNov 12, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING SERVICE THIS 980 VENTILATOR FAILED THE SHORT SELF TEST (SST) CIRCUIT PRESSURE TEST. 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 20669507 ↗
• MalfunctionNov 1, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR ENTERED BACKUP VENTILATION (BUV). THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20591518 ↗
• MalfunctionOct 10, 2024Improper Flow or Infusion; Infusion or Flow Problem; Improper Flow or Infusion; Infusion or Flow Problem

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THE THERE WAS AN ISSUE WITH THE ATMOSPHERIC PRESSURE AND THE TIDAL VOLUME AND MINUTE VOLUME DISPLAYED ON THIS 980 VENTILATOR WAS GREATER THAN WHAT WAS SET. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20423135 ↗
• MalfunctionSep 17, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT WHILE IN USE, ON A PATIENT THIS 980 VENTILATOR GENERATED AN ALARM "BUT THE ALARM DID NOT SOUND AND THE STATUS INDICATOR LIGHTS REMAINED NORMAL (GREEN)." THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED. THE LOGS WERE REVIEWED AND THERE IS NO EVIDENCE THAT THE ALARM DID NOT RING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238833 ↗
• MalfunctionJul 5, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING SERVICE THIS 980 VENTILATOR'S SHORT SELF TEST (SST) CIRCUIT PRESSURE TEST FAILED WITH THE MESSAGE "INSPIRATORY SOLENOID DOES NOT OPERATE". 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 19684209 ↗
• MalfunctionJun 26, 2024No Flow; Power Problem; No Flow; Power Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR DID NOT WORK AFTER POWER ON. 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 19619772 ↗
• MalfunctionJun 17, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR ENTERED BACKUP VENTILATION. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE VENTILATOR WITHOUT INJURY. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547529 ↗
• MalfunctionJun 14, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING SERVICING THIS 980 VENTILATOR FAILED THE CIRCUIT PRESSURE TEST WHILE PERFORMING THE 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 19543506 ↗
• MalfunctionFeb 29, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR GENERATED A ¿BACKUP VENTILATION¿ ALARM. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808095 ↗
• MalfunctionFeb 9, 2024Smoking; Smoking

  IT WAS REPORTED THAT UPON TURNING ON, THIS 980 VENTILATOR¿S EXHALATION VALVE MADE ABNORMAL MOVEMENTS THEN SMOKE WAS EMITTED AFTERWARDS. 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 18682078 ↗
• MalfunctionJan 5, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THIS 980 VENTILATOR GENERATED A SAFETY VALVE OPEN (SVO) ALARM AND VENTILATION STOPPED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. REVIEW OF THE LOGS CONFIRMED A LOSS OF VENTILATION AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18455218 ↗
• MalfunctionDec 27, 2023No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT THIS 980 VENTILATOR GENERATED AN INOPERATIVE (VENT INOP) ALARM. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. A REVIEW OF THE LOGS INDICATE A LOSS OF VENTILATION AT THE TIME OF REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401494 ↗