Puritan Bennett 980X1ESDIECRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884521171633), received between Mar 30, 2017 and May 2, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (10 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Erratic or Intermittent Display; Device Emits Odor; No Flow; Erratic or Intermittent Display; Device Emits Odor; No Flow

  IT WAS REPORTED THAT DURING THE SHORT SELF TEST (SST) ON THIS 980 VENTILATOR, THE VENTILATOR HAD A BLACK SCREEN AND WAS NOTED THERE WAS A "BURNED SMELL". THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. REPORTABILITY WAS REASSESSED BASED ON FIELD SERVICE ENGINEER FINDINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950581 ↗
• MalfunctionJan 24, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATORS FAILED THE EXTENDED SELF TEST (EST). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21230907 ↗
• MalfunctionAug 23, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THESE 980 VENTILATORS 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 EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20052881 ↗
• MalfunctionMar 13, 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). 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 18895088 ↗
• MalfunctionNov 9, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR'S 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 18103501 ↗
• MalfunctionNov 9, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THE 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 18103256 ↗
• MalfunctionOct 19, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR OXYGEN (O2) PROPORTIONAL SOLENOID VALVE (PSOL) HAD A LEAK. 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 17971208 ↗
• MalfunctionOct 3, 2023Improper 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). 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 17862466 ↗
• MalfunctionAug 22, 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 17596958 ↗
• MalfunctionJun 19, 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 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 17159614 ↗
• MalfunctionMay 9, 2023Obstruction of Flow; Improper Flow or Infusion; Obstruction of Flow; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THIS 980 VENTILATOR ALARMED A SEVERE OCCLUSION. PATIENT OUTCOME WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899576 ↗
• MalfunctionDec 31, 2021No Flow; No Flow

  IT WAS REPORTED THAT, WHEN CONNECTED TO A PATIENT, A 980 VENTILATOR "DEVICE GETS STUCK." THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED VIA AN AMBU BAG BEFORE BEING PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY. A REVIEW OF THE DIAGNOSTIC LOGS INDICATES THERE WAS EVIDENCE OF A LOSS OF VENTILATION AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13128752 ↗
• MalfunctionJul 19, 2018No Audible Alarm; Loss of Power; No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR SHUT DOWN AND GENERATED AN AUDIBLE ALARM. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7704940 ↗
• MalfunctionJun 5, 2018Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR DISPLAY TURNED OFF, ALARMED CONSTANTLY AND STOPPED CYCLING WHILE IN PRESSURE SUPPORT MODE. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Code Available

  MAUDE report 7571772 ↗
• MalfunctionJan 31, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR ALARMED WITH ERROR CODES, WAS INOPERABLE AND BEGAN BACKUP VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Code Available

  MAUDE report 7230814 ↗
• MalfunctionAug 23, 2017Failure to Deliver; Failure to Deliver

  THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6814254 ↗
• MalfunctionJul 27, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT A 980 VENTILATOR HAD A BATTERY FAILURE. ALTHOUGH REQUESTED, INFORMATION PERTAINING TO THE USE OF THE DEVICE AT THE TIME OF THE REPORTED EVENT AND PATIENT OUTCOME (IF APPLICABLE) HAS NOT BEEN PROVIDED.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6747840 ↗
• MalfunctionJul 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 980 VENTILATOR HAD AN OXYGEN (O2) SENSOR FAILURE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE SE CALIBRATED THE O2 SENSOR AND PERFORMED EXTENDED SELF TESTING. ALL TESTS PASSED.

  Patient problems: No Patient Involvement

  MAUDE report 6684807 ↗
• MalfunctionMar 30, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT, A 980 VENTILATOR FAILED THE POWER ON SELF TEST (POST) AND GENERATED AN INOPERABLE ERROR MESSAGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND A DIAGNOSTIC CODE RELEVANT TO THE REPORTED INCIDENT RECORDED IN THE VENTILATORS MEMORY LOGS. THE SE REPLACED THE POWER SUPPLY. THE SE UPDATED THE SOFTWARE TO THE CURRENT REVISION, PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Patient Involvement

  MAUDE report 6448594 ↗