Puritan Bennett 980A1ENNISBRecalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10884521201897), received between May 1, 2017 and Aug 20, 2025 — classified as 86 malfunctions.

The most frequently reported specific device problem is “Output Problem” (29 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-0338-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR HAD A SYSTEM ERROR. 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 22854110 ↗
• MalfunctionJun 12, 2025No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR HAD A LOSS OF VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THERE WAS NO REPORTED INJURY TO THE PATIENT. POST VENTILATOR TRANSFER, THE DEVICE DID NOT PASS THE POWER ON SELF TEST (POST).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199396 ↗
• MalfunctionJun 12, 2025No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR EXPERIENCED A LOSS OF VENTILATION (LOV). THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199375 ↗
• MalfunctionApr 1, 2025Smoking; Smoking

  IT WAS REPORTED THAT BEFORE THE PREVENTIVE MAINTENANCE WAS PERFORMED ON THESE 980 VENTILATORS, THE VENTILATOR "HAD TICKING SOUNDS WHEN IT WAS TURNED ON AND WITHIN 10 SECONDS SMOKE WAS OBSERVED COMING FROM THE EXPIRATORY SIDE AND INHALATION FAN". 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 21742443 ↗
• MalfunctionDec 12, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR HAD A ¿MALFUNCTION¿ AND DISPLAYED MESSAGES "VENTILATOR - INOPERATIVE, EST REQUIRED, AND DEVICE ALERT." THE PATIENT WAS REMOVED FROM THE VENTILATOR, MANUALLY VENTILATED, AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY. AFTER PATIENT REMOVAL, IT WAS REPORTED THAT THE VENTILATOR FAILED THE POWER ON SELF TEST (POST) WITH THE MESSAGE SHORT SHELF TEST NOT ALLOWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920873 ↗
• MalfunctionNov 13, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE EXTENDED SELF TEST (EST) 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 20679240 ↗
• MalfunctionSep 27, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR GENERATED AN EXTENDED SELF TEST (EST) FAILURE DIAGNOSTIC CODE 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 20322981 ↗
• MalfunctionSep 13, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20214480 ↗
• MalfunctionSep 11, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THE 980 VENTILATOR FAILED THE CIRCUIT PRESSURE TEST WITH "INSPIRATORY AUTO ZERO SOLENOID NOT OPERATIONAL MESSAGE" DURING 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 20197281 ↗
• MalfunctionJan 2, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THE 980 VENTILATOR FAILED THE EXTENDED SELF TEST WITH AN 'INSPIRATORY 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 18427108 ↗
• MalfunctionJan 2, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE EXTENDED SELF TEST (EST) 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 18427090 ↗
• MalfunctionJan 2, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE EXTENDED SELF TEST (EST) 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 18427075 ↗
• MalfunctionJan 2, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED 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 18427047 ↗
• MalfunctionSep 12, 2023Smoking; Smoking

  IT WAS REPORTED THAT THIS 980 VENTILATOR WAS EMITTING SMOKE. 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 17733141 ↗
• MalfunctionAug 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 WITH AN "INSPIRATORY AUTO ZERO SOLENOID NOT OPERATIONAL" DURING 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 17549696 ↗
• MalfunctionAug 2, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR EXTENDED SELF TEST (EST) FAILED AT THE "CIRCUIT PRESSURE STEP "INSPIRATORY 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 17445530 ↗
• MalfunctionJul 10, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS  980 VENTILATOR FAILED THE CIRCUIT PRESSURE TEST WITH AN "INSPIRATORY AUTO ZERO SOLENOID NOT OPERATIONAL" DURING 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 17293384 ↗
• MalfunctionJul 10, 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 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 17292745 ↗
• MalfunctionJun 19, 2023Product Quality Problem; Improper Flow or Infusion; Product Quality Problem; Improper Flow or Infusion

  IT WAS REPORTED DURING INSTALLATION THAT THIS 980 VENTILATOR HAD A FAILURE OUT OF BOX (FOOB) DUE TO FAILING THE CIRCUIT PRESSURE TEST DURING THE EXTENDED SELF-TEST (EST) AND DISPLAYED THE ERROR MESSAGE "INSPIRATORY AUTOZERO SOLENOID NOT OPERATIONAL" AND CORRESPONDING 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 17155637 ↗
• MalfunctionFeb 2, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THE 980 VENTILATOR FAILED THE CIRCUIT PRESSURE PORTION OF THE SHORT SELF TESTING (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 16287881 ↗
• MalfunctionJan 30, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR DID NOT PASS THE INSPIRATORY AUTO ZERO SOLENOID 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 16264974 ↗
• MalfunctionJan 25, 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 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 16240849 ↗
• MalfunctionJan 25, 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 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 16240843 ↗
• MalfunctionJan 17, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT A 980 VENTILATOR FAILED THE EXTENDED SELF TEST (EST) AND SHORT SELF TEST (SST) WITH DIAGNOSTIC CODES. 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 16186709 ↗
• MalfunctionJan 4, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR DISPLAYED A "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 16096230 ↗