Puritan Bennett 980U1ENDICURecalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10884521171138), received between Jan 16, 2018 and Apr 13, 2026 — classified as 2 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (57 reports).

2 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. 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 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR GENERATED ALARM ¿VENTILATOR INOPERATIVE, SAFETY VALVE OPEN, REPLACE 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 24866467 ↗
• MalfunctionMar 24, 2026No Flow; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR DID NOT PASS THE CIRCUIT PRESSURE TEST PORTION OF THE SHORT SELF TEST (SST) WITH AN "INSPIRATORY AND SAFETY VALVE PRESSURE SENSOR DIFFERENCE OUTSIDE TEST LIMITS" 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 24683164 ↗
• MalfunctionJan 29, 2026Defective Alarm; Output Problem

  IT WAS REPORTED THAT THE 980 VENTILATOR DID NOT PASS THE BREATH DELIVERY (BD) AUDIO TEST PORTION OF THE EXTENDED SELF TEST (EST). THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24215018 ↗
• MalfunctionOct 22, 2025Device Emits Odor; No Flow; Device Emits Odor; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THIS 980 VENTILATOR ALARMED, STOPPED VENTILATING, HAD A BLACK SCREEN AND HAD A BURNING SMELL. "THE PATIENT BEGAN TO DESATURATE AND REQUIRED MANUAL VENTILATION WITH A BAG-VALVE MASK." 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 23363425 ↗
• MalfunctionSep 2, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING USE ON A PATIENT REQUIRING SUPPORTED BREATHS WHILE ON CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP), THE 980 VENTILATOR ACTIVATED BACKUP VENTILATION MODE. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE VENTILATOR WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22947919 ↗
• MalfunctionMay 9, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING SCHEDULED MAINTENANCE THIS 980 VENTILATOR DID NOT PASS THE CIRCUIT PRESSURE TEST PORTION OF THE EXTENDED SELF TEST (EST) WITH AN "EXHALATION 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 21997446 ↗
• MalfunctionApr 1, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE "CIRCUIT PRESSURE TEST" DURING EXTENDED SELF TEST (EST) AND WAS FAILING EST AND SHORT SELF TEST (SST) REPEATEDLY. 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 21742952 ↗
• MalfunctionOct 2, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR DID NOT PASS 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 20352418 ↗
• MalfunctionSep 23, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THESE 980 VENTILATORS DID NOT PASS 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 20284508 ↗
• MalfunctionSep 5, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE SHORT SELF TEST (SST) WITH AN "EXHALATION AUTOZERO SOLENOID NOT OPERATIONAL" MESSAGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20153216 ↗
• MalfunctionApr 3, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED CIRCUIT PRESSURE TEST DURING SHORT SELF-TEST (SST) 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 19035528 ↗
• MalfunctionMar 20, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE SHORT SELF TEST (SST) 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 18946823 ↗
• MalfunctionMar 19, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE SHORT SELF-TEST (SST) WITH AN "EXHALATION AUTO ZERO SOLENOID NOT OPERATIONAL" ME SSAGE. 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 18937889 ↗
• MalfunctionJan 17, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT 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 18531751 ↗
• MalfunctionDec 21, 2023Improper 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 INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18373138 ↗
• MalfunctionDec 7, 2023No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR DID NOT PASS 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 18288278 ↗
• MalfunctionNov 21, 2023Improper 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 PORTION OF 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 18184870 ↗
• MalfunctionNov 20, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE SHORT SELF-TEST (SST) CIRCUIT PRESSURE TEST 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 18173386 ↗
• MalfunctionNov 15, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE CIRCUIT PRESSURE TEST DURING THE SHORT SELF-TEST (SST) WITH AN "INSPIRATORY AUTO ZERO SOLENOID NOT OPERATIONAL" ERROR 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 18144211 ↗
• MalfunctionNov 7, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR'S SHORT SELF TEST (SST) CIRCUIT PRESSURE TEST WITH "EXHALATION AUTO ZERO SOLENOID NOT OPERATIONAL".  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 18088164 ↗
• MalfunctionNov 6, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR GENERATED A HIGH PRIORITY ALARM INDICATING THAT THE VENTILATOR WAS NOT VENTILATING AND THE MAIN TOUCH SCREEN WAS NOT OPERABLE. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. ALTHOUGH IT WAS REPORTED THAT THE VENTILATOR WAS NOT VENTILATING THE PATIENT, PER CODE PROVIDED BY THE FACILITY, THE DEVICE ENTERED INTO BACKUP VENTILATION (BUV) AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074349 ↗
• MalfunctionOct 19, 2023Device Emits Odor; No Flow; Device Emits Odor; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR SHUT OFF AND EMITTED A BURNING PLASTIC SMELL. THE 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 17967066 ↗
• MalfunctionOct 16, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR GENERATED A EXTENDED SELF TEST (EST) 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 17942316 ↗
• MalfunctionOct 13, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT 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 17934938 ↗
• MalfunctionOct 13, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE CIRCUIT PRESSURE TEST PORTION OF SHORT SELF TEST (SST) WITH A "INSPIRATORY AUTOZERO SOLENOID NOT OPERATIONAL" MESSAGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. REPORTABILITY WAS REASSESSED BASED ON THE PRODUCT ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17934884 ↗