Puritan Bennett 980X3ENDIUURecalls & reported problems

Summary

The FDA's MAUDE database contains 827 adverse event reports that list this exact device (DI 10884521172524), received between Aug 24, 2017 and Sep 28, 2026 — classified as 3 deaths, 2 injuries, 822 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (580 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-0352-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 827 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Smoking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926498 ↗
• MalfunctionJun 18, 2026Output Problem

  IT WAS REPORTED THAT THE 980 VENTILATOR DID NOT PASS THE SHORT SELF TEST (SST) AND EXTENDED SELF TEST (EST) FOR THE AUTO ZERO TRANSDUCER ON THE EXHALATION SIDE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25546589 ↗
• MalfunctionMay 27, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR WAS IN AN INOPERATIVE STATUS. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300335 ↗
• MalfunctionMay 14, 2026Mechanical Problem; No Flow

  IT WAS REPORTED THAT DURING ANNUAL PREVENTATIVE MAINTENANCE PERFORMED BY MEDTRONIC, THIS 980 VENTILATOR WAS FOUND TO HAVE DAMAGE TO THE DIRECT CURRENT (DC) - DC PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). 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 25178428 ↗
• MalfunctionApr 29, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR GENERATED A BACKGROUND ALERT INDICATING THE VENTILATOR ENTERED INTO 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 25032335 ↗
• MalfunctionApr 14, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT THE 980 VENTILATOR GENERATED A MIX AIR FLOW OUT OF RANGE BACKGROUND DIAGNOSTIC CODE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877893 ↗
• MalfunctionMar 31, 2026Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THE 980 VENTILATOR GENERATED A MESSAGE INDICATING THAT A EXTENDED SELF TEST (EST) WAS REQUIRED. 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 24744959 ↗
• MalfunctionMar 24, 2026No Flow

  IT WAS REPORTED THAT WHILE SETTING UP THE 980 VENTILATOR TO RUN SST, THE VENTILATOR WENT INOPERATIVE WITH DIAGNOSTIC CODES INDICATING AN ISSUE WITH THE DIRECT CURRENT (DC)-DC CONVERTER PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681492 ↗
• MalfunctionMar 18, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT THIS 980 VENTILATOR DID NOT PASS THE EXHALATION VALVE (EV) PERFORMANCE TEST PORTION OF THE SHORT SELF TEST (SST) WITH A MESSAGE INDICATING THE PRESSURE WAS OUT OF RANGE (OOR). THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627348 ↗
• MalfunctionMar 5, 2026No Flow

  IT WAS REPORTED THAT THE 980 VENTILATOR WOULD NOT STAY POWERED ON WHILE OPERATING ON BATTERY POWER AND WOULD SHUT OFF AS SOON AS IT WAS UNPLUGGED FROM THE WALL OUTLET. THERE WAS NO PATIENT INVOLVED. HOWEVER, A REVIEW OF THE VENTILATOR LOGS INDICATE THAT THERE WAS A LOSS OF VENTILATION (LOV) WHILE IN USE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521551 ↗
• MalfunctionFeb 27, 2026Smoking; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR'S SCREEN WENT BLACK, THEN WHEN THE SCREEN CAME ON CLINICIANS SAW SMOKE COMING FROM THE BACK OF THE VENTILATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475247 ↗
• MalfunctionJan 29, 2026No Flow

  IT WAS REPORTED THAT THIS 980 VENTILATOR WAS IN AN INOPERATIVE CONDITION. THERE WAS NO PATIENT INVOLVED. A REVIEW OF THE VENTILATOR LOGS SHOW A LOSS OF VENTILATION OCCURRING AFTER AN ATTEMPT TO ENTER INTO BACKUP VENTILATION (BUV) WHICH APPEARS TO HAVE OCCURRED DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210750 ↗
• MalfunctionJan 28, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT THIS 980 VENTILATOR WAS IN AN INOPERATIVE CONDITION. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24203368 ↗
• MalfunctionJan 8, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THIS 980 VENTILATOR "SWITCHED OFF". THERE WAS NO REPORTED PATIENT INJURY. AFTER A REVIEW OF THE VENTILATOR LOGS THERE WAS NO EVIDENCE THE VENTILATOR SHUT DOWN DURING USE. THERE WAS HOWEVER, EVIDENCE IN THE VENTILATOR LOGS THAT THE VENTILATOR ENTERED INTO BACKUP VENTILATION (BUV).

  Patient problems: Insufficient Information

  MAUDE report 24011925 ↗
• MalfunctionDec 17, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR GENERATED ERROR MESSAGES. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23834726 ↗
• MalfunctionNov 26, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING USE OF THE 980 VENTILATOR ON A PATIENT, A BACKGROUND FAULT WAS DETECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657361 ↗
• MalfunctionNov 20, 2025Device Emits Odor; No Flow; Output Problem; Noise, Audible; Device Emits Odor; No Flow; Output Problem; Noise, Audible

  IT WAS REPORTED THAT THE 980 VENTILATOR MADE A LOUD NOISE, HAD A BURNT SMELL, AND DID NOT PASS THE "MIX SUBSYSTEM TEST", "INSPIRATORY SUBSYSTEM TEST" AND EXHALATION SUBSYSTEM TEST" DURING THE POWER ON SELF TEST (POST). THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607581 ↗
• MalfunctionOct 30, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THE 980 VENTILATOR DID NOT PASS THE SHORT SELF TEST (SST). THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430204 ↗
• MalfunctionOct 20, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THIS 980 VENTILATOR DID NOT PASS THE INSPIRATORY AUTOZERO OFFSET DURING THE EXTENDED SELF TEST (EST). THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343068 ↗
• MalfunctionOct 16, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THE 980 VENTILATOR DID NOT PASS THE EXTENDED SELF TEST (EST) AND SHORT SELF TEST (SST). THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318569 ↗
• MalfunctionOct 16, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THE EXTENDED SELF TEST (EST) PERFORMED ON THE 980 VENTILATOR DID NOT PASS, DISPLAYING THE MESSAGE "INSPIRATORY AUTOZERO SOLENOID NOT OPERATIONAL." THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23317395 ↗
• MalfunctionOct 15, 2025No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR DID NOT PASS 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 23306188 ↗
• MalfunctionOct 15, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THE 980 VENTILATOR FAILED THE CIRCUIT PRESSURE TEST WITH AN "INSPIRATORY AUTO ZERO SOLENOID NOT OPERATIONAL" MESSAGE, DURING THE EXTENDED SELF TEST (EST) AND SHORT SELF TEST (SST). THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286526 ↗
• MalfunctionSep 19, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING THE PREVENTIVE MAINTENANCE OF THIS 980 VENTILATOR, THE VENTILATOR DID NOT PASS THE EXTENDED SELF TEST (EST) AS THE INSPIRATORY SOLENOID WAS READING OUT OF RANGE (OOR) DURING THE CIRCUIT PRESSURE TEST. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100313 ↗
• MalfunctionSep 9, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THE 980 VENTILATOR'S AUTO ZERO SOLENOID WAS NOT OPERATIONAL AND THE VENTILATOR DID NOT PASS THE EXTENDED SELF TEST (EST) OR THE SHORT SELF TEST (SST). THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23011821 ↗