Puritan Bennett 980X1ENDIUURecalls & reported problems

Summary

The FDA's MAUDE database contains 562 adverse event reports that list this exact device (DI 10884521171541), received between Mar 9, 2017 and Jun 25, 2026 — classified as 1 death, 7 injuries, 554 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (385 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-0347-2022 · 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 562 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THIS 980 VENTILATOR GENERATED 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 25619696 ↗
• MalfunctionJun 19, 2026Improper Flow or Infusion; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25562364 ↗
• MalfunctionJun 12, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT THIS 980 VENTILATOR DID NOT PASS THE EXHALATION SUBSYSTEM PORTION OF THE POWER ON SELF TEST (POST) WITH A PNEUMATICS INTERFACE EXHALATION ANALOG-DIGITAL CONVERTER (ADC) OUT OF RANGE 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 25488633 ↗
• MalfunctionMay 22, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 980 VENTILATOR WAS INOPERATIVE (VENT INOP). 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 25260270 ↗
• MalfunctionApr 30, 2026No Flow; Output Problem

  IT WAS REPORTED THAT DURING CUSTOMER PREVENTATIVE MAINTENANCE THIS 980 VENTILATOR DISPLAYED AN "EXTENDED SELF TEST (EST) NEVER RAN" MESSAGE WHEN ENTERING NORMAL VENTILATION MODE. 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 25045221 ↗
• MalfunctionMar 31, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR DISPLAYED MESSAGE VENTILATOR INOPERATIVE AND A BACKGROUND DIAGNOSTIC CODE INDICATING VENTILATOR HAD ENTERED BACKUP VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY. AFTER THE PATIENT HAD BEEN REMOVED FROM THE VENTILATOR THE BIOMEDICAL ENGINEER (BIOMED) OBSERVED THE VENTILATOR DISPLAYED MESSAGE ¿EXTENDED SELF TEST (EST) NEVER RUN" AND FOUND BACKGROUND DIAGNOSTIC CODES INDICATING INSPIRATORY PROPORTIONAL (PSOL) STUCK AND PNEUMATIC INTERFACE ANALOG TO DIGITAL CONVERTER FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746888 ↗
• MalfunctionMar 24, 2026Improper Flow or Infusion

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682766 ↗
• MalfunctionMar 24, 2026No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE 980 VENTILATOR WAS INOPERATIVE (VENT INOP) AND GENERATED MULTIPLE DIRECT CURRENT (DC) VOLTAGE OUT-OF-RANGE ERRORS. 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 24677208 ↗
• MalfunctionJan 28, 2026No Flow

  IT WAS REPORT THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR GENERATED A VENTILATOR INOPERATIVE MESSAGE. 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 24203214 ↗
• MalfunctionJan 9, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE 980 VENTILATOR ENTERED INTO BACKUP VENTILATION (BUV). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022007 ↗
• MalfunctionDec 17, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THIS 980 VENTILATOR GENERATED A BACKGROUND FAULT ALERT WITH "SYSTEM FAILURE" AND "LOSS OF BREATH DELIVERY (BD) COMMUNICATION" MESSAGES. 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 23831746 ↗
• MalfunctionDec 4, 2025Smoking; No Flow; Smoking; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THIS 980 VENTILATOR WAS SEEN TO HAVE SMOKE COMING FROM THE FRONT OF THE VENTILATOR. 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 23717203 ↗
• MalfunctionNov 26, 2025No Flow; No Flow

  IT WAS REPORTED THAT THE 980 VENTILATOR STOPPED VENTILATING WHILE IN USE ON A PATIENT. 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 23659546 ↗
• MalfunctionNov 26, 2025Defective Alarm; Output Problem; Defective Alarm; Output Problem

  IT WAS REPORTED THAT WHEN THE CUSTOMER DISCONNECTED THE AIR FROM THE VENTILATOR, THEY ONLY SAW A VISUAL ALARM DISPLAYED BUT CUSTOMER WAS EXPECTING BOTH A VISUAL AND AUDIBLE ALARM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657224 ↗
• MalfunctionNov 19, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE 980 VENTILATOR GENERATED A BACKGROUND FAULT CODE FOR "MIX AIR FLOW SENSOR READING OUT OF RANGE", INDICATING THAT THE VENTILATOR ENTERED BACKUP VENTILATION (BUV). THE PATIENT WAS TRANSFERRED TO AN ALTERNATE VENTILATOR WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23600657 ↗
• MalfunctionNov 14, 2025No Flow; No Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560808 ↗
• MalfunctionOct 31, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THIS 980 VENTILATOR DID NOT PASS THE SHORT SELF TEST (SST) DISPLAYING AN INSPIRATORY AUTOZERO NON-OPERATIONAL MESSAGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441338 ↗
• MalfunctionOct 15, 2025No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT THE 980 VENTILATOR DID NOT PASS THE POWER ON SELF TEST (POST). THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303531 ↗
• MalfunctionSep 15, 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 SHORT SELF TEST (SST) AND 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 23052097 ↗
• MalfunctionSep 12, 2025No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR ¿FAILED¿ WITH LOSS OF THE BREATH DELIVERY COMMUNICATION MESSAGE. 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 23043318 ↗
• MalfunctionSep 12, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THESE 980 VENTILATORS GENERATED A HIGH ALERT WITH A "MIX AIR FLOW SENSOR READING OUT OF RANGE (OOR)" MESSAGE AND ENTERED MIX 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 23039866 ↗
• MalfunctionSep 5, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THE 980 VENTILATOR FAILED THE EXHALATION AUTOZERO SOLENOID TEST DURING 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 22980078 ↗
• MalfunctionSep 4, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR'S OXYGEN (O2) SENSOR WAS OUT OF RANGE. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. A REVIEW OF THE LOGS SHOWED THAT THE DEVICE ENTERED INTO BACKUP VENTILATION (BUV) AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22967220 ↗
• MalfunctionAug 28, 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) WITH THE EXHALATION SOLENOID WAS NOT OPERATIONAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919366 ↗
• MalfunctionAug 13, 2025Defective Alarm; Problem with Software Installation; Defective Alarm; Problem with Software Installation

  IT WAS REPORTED THAT DURING SERVICING, THE 980 VENTILATOR FAILED THE SOFTWARE DOWNLOAD. 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 22795831 ↗