Puritan Bennett 980X1JADIJJRecalls & reported problems

Summary

The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 10884521171558), received between Apr 3, 2017 and Jun 19, 2026 — classified as 3 injuries, 158 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (86 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-0349-2022 · 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 25 most recent of 161 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING SERVICE THIS 980 VENTILATOR GENERATED TWO BACKGROUND CODES INSPIRATORY PRESSURE AUTO OFFSET FAILED AND PNEUMATIC DIGITAL CONVERTER FAILURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25561763 ↗
• MalfunctionMay 22, 2026Product Quality Problem; No Flow

  IT WAS REPORTED THAT DURING ANNUAL PREVENTATIVE MAINTENANCE, WHEN THIS 980 VENTILATOR HAD A NEW BREATH DELIVERY (BD) POWER CONTROL DISTRIBUTION ASSEMBLY WAS REPLACED, WHEN IT WAS POWERED ON, IT ALARMED, WOULD NOT START UP AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25255627 ↗
• MalfunctionJan 2, 2026Erratic or Intermittent Display; Device Emits Odor; No Flow; Noise, Audible

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR HAD A "POPPING SOUND AND A BURNING SMELL". VENTILATION CONTINUED, BUT THE SCREEN BLACKED OUT AND A RED "WARNING LAMP" TURNED ON. THERE WAS NO INJURY TO THE PATIENT. ALTHOUGH IT WAS REPORTED THAT VENTILATION CONTINUED, A REVIEW OF THE LOGS INDICATE THE VENTILATOR HAD A LOSS OF VENTILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944519 ↗
• MalfunctionNov 25, 2025No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT, DURING SERVICING, THIS 980 VENTILATOR DID NOT PASS THE LEAK TEST PORTION OF THE EXTENDED SELF TEST (EST). THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649733 ↗
• MalfunctionNov 6, 2025No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT THIS 980 VENTILATOR'S SCREEN TURN OFF AND THE VENTILATOR SHUT DOWN. 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 23488007 ↗
• MalfunctionOct 31, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT, DURING SERVICING, THE 980 VENTILATOR DID NOT PASS THE CIRCUIT PRESSURE TEST PORTION OF THE SHORT SELF TEST (SST) WITH MESSAGE INSPIRATORY AUTO ZERO SOLENOID DID NOT OPERATE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441845 ↗
• MalfunctionOct 15, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR HAD A "BACKGROUND ERROR" DISPLAYED. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304489 ↗
• MalfunctionSep 16, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THIS 980 VENTILATOR GENERATED A BACKUP VENTILATION (BUV) CONDITION, EXHALATION AUTOZERO ISSUE. 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 23065264 ↗
• MalfunctionSep 5, 2025Improper 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) WITH AN EXHALATION 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 22979822 ↗
• MalfunctionAug 29, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THIS 980 VENTILATOR ALARMED WITH A SYSTEM ERROR MESSAGE, "VENTILATION STOPPED", AND D ISPLAYED A "MIX SUBSYSTEM TEST" POWER ON SELF TEST (POST) ERROR CODE. 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 22922322 ↗
• MalfunctionAug 26, 2025No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR ACTIVATED AN ALARM AND VENTILATION STOPPED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY. A REVIEW OF THE VENTILATOR LOGS CONFIRMED THE REPORTED LOSS OF VENTILATION (LOV).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900051 ↗
• MalfunctionJul 9, 2025Improper 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) WITH AN "EXHALATION 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 22464374 ↗
• MalfunctionJun 20, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THIS 980 VENTILATOR STOPPED. THERE WERE MULTIPLE OUT OF RANGE ERROR CODES INDICATING MIX BACKUP VENTILATION (BUV) ACTIVATION FAILURE. 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 22297918 ↗
• MalfunctionJun 9, 2025No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR GENERATED AN ALARM SOUND AND VENTILATION STOPPED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168829 ↗
• MalfunctionMay 23, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, DURING SERVICING BY MEDTRONIC SERVICE PERSONNEL, THESE 980 VENTILATORS DID NOT PASS THE SHORT SELF TEST (SST). THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078011 ↗
• MalfunctionMay 21, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THIS 980 VENTILATOR DISPLAYED AN INSPIRATORY AUTOZERO SOLENOID ERROR MESSAGE AND ENTERED INTO BACKUP VENTILATION (BUV). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066551 ↗
• MalfunctionApr 9, 2025No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR ALARMED, THE SCREEN WAS BLACK, VENTILATION STOPPED AND THERE WAS A BURNT SMELL. WHEN THE POWER WAS TURNED BACK ON NOTHING WORKED. THE PATIENT'S PERIPHERAL CAPILLARY OXYGEN SATURATION (SPO2) DECREASED. THERE WAS NO INJURY TO THE PATIENT. A REVIEW OF THE VENTILATOR LOGS CONFIRMED THE REPORTED LOSS OF VENTILATION.

  Patient problems: Low Oxygen Saturation

  MAUDE report 21807114 ↗
• MalfunctionMar 26, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE RUNNING ON A TEST LUNG, THESE 980 VENTILATORS ENTERED INTO 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 21703854 ↗
• MalfunctionMar 25, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR DID NOT PASS THE SHORT SELF TEST (SST) WITH AN "INSPIRATORY AUTO ZERO SOLENOID NOT OPERATIONAL" 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 21689006 ↗
• MalfunctionFeb 18, 2025Device Emits Odor; No Flow; Device Emits Odor; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR'S SCREEN WAS NO LONGER DISPLAYED, A "SHORT BEEPING" SOUND WAS HEARD, THERE WAS A BURNED SMELL, AND VENTILATION STOPPED. 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 21404813 ↗
• 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 POWER ON SELF TEST (POST). 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 20669067 ↗
• MalfunctionOct 24, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THIS 980 VENTILATOR ALARMED AND WENT INTO BACKUP 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 20525836 ↗
• MalfunctionOct 22, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING SERVICE THIS 980 VENTILATOR SHORT SELF TEST (SST) 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 20510545 ↗
• MalfunctionOct 14, 2024No Flow; No Flow

  IT WAS REPORTED THAT, DURING USE, THIS 980 VENTILATOR¿S ¿SCREEN BLACKED OUT, THE POWER WENT OFF AFTER THE BEEP ALARM SOUNDED AND THEN STARTED UP AND OPERATED.¿ THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20447061 ↗
• MalfunctionOct 14, 2024Smoking; No Flow; Smoking; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR HAD AN ALARM AND TURNED OFF. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE VENTILATOR WITHOUT INJURY. AFTER REMOVING THE VENTILATOR FROM THE PATIENT, THE CUSTOMER ATTEMPTED TO POWER ON THE VENTILATOR WHICH WOULD NOT POWER ON. SMOKE AND A BURNING SMELL CAME FROM THE AREA AROUND THE POWER SWITCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20446809 ↗