Puritan Bennett 980A3ENNISBRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10884521201910), received between May 8, 2017 and Mar 19, 2025 — classified as 1 death, 23 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (9 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-0339-2022 · 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR WAS IN AN INOPERATIVE CONDITION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND TRANSFERRED TO AN ALTERNATE VENTILATOR WITHOUT INJURY. A REVIEW OF THE VENTILATOR LOGS SHOW THAT THE UNIT EXPERIENCED A LOSS OF VENTILATION TO THE PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21647778 ↗
• MalfunctionMar 10, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR ALARMED AND DISPLAYED MESSAGE ¿BACKUP VENTILATION (BUV), ¿VENTILATOR INOPERATIVE¿. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21566431 ↗
• MalfunctionJul 1, 2024No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR HAD A SYSTEM FAILURE. 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 19648725 ↗
• MalfunctionSep 11, 2023Improper 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 WITH AND "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 17725635 ↗
• MalfunctionJun 30, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THE 980 VENTILATOR FAILED THE CIRCUIT PRESSURE CHECK 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 17238388 ↗
• MalfunctionApr 26, 2023Improper 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 16818258 ↗
• 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 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 16264973 ↗
• MalfunctionJan 23, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT A 980 VENTILATOR FAILED THE SHORT SELF TEST (SST) CIRCUIT PRESSURE TEST WITH A 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 16229091 ↗
• MalfunctionDec 22, 2022Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING MAINTENANCE, THE 980 VENTILATOR FAILED THE EXTENDED SELF TEST (EST) WITH A 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 16036037 ↗
• MalfunctionNov 29, 2022Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT A 980 VENTILATOR FAILED THE EXTENDED SELF TEST (EST) WITH A 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 15883160 ↗
• MalfunctionSep 21, 2021Product Quality Problem; No Flow; Output Problem; Product Quality Problem; No Flow; Output Problem

  CORRECTED EVENT DESCRIPTION: IT WAS REPORTED THAT, WHEN POWERING ON, A 980 VENTILATOR GENERATED A POWER ON SELF TEST (POST) FAILURE 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 12510173 ↗
• MalfunctionApr 30, 2021Smoking; Smoking

  IT WAS REPORTED THAT, WHEN THIS 980 VENTILATOR WAS POWERED ON, THE VENTILATOR HAD SMOKE EMERGING FROM THE GRAPHICAL USER INTERFACE (GUI). 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 11752673 ↗
• MalfunctionNov 30, 2020Failure to Charge; Contamination /Decontamination Problem; No Flow; Power Problem; Failure to Charge; Contamination /Decontamination Problem; No Flow; Power Problem

  IT WAS REPORTED THAT A 980 VENTILATOR WAS UNABLE TO BE TURNED ON, HAD A BURNT SMELL AND BATTERIES THAT COULDN'T BE CHARGED. 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 10920076 ↗
• MalfunctionOct 12, 2020Smoking; Smoking

  IT WAS REPORTED THAT DURING TESTING, SMOKE EMERGED FROM THE 980 VENTILATOR BREATH DELIVERY UNIT (BDU) ELECTRONIC SIDE WHEN IT WAS TURNED ON. THE UNIT WAS REPORTED TO HAVE ALARMED LOUDLY "SYSTEM ERROR". THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10667750 ↗
• MalfunctionMay 27, 2020Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR GENERATED AN ALARM AND ENTERED ¿BACKUP VENTILATION¿. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10093955 ↗
• MalfunctionFeb 27, 2020Contamination /Decontamination Problem; No Flow; Contamination /Decontamination Problem; No Flow

  IT WAS REPORTED THAT A 980 VENTILATOR HAD A BURNT SMELL. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9764583 ↗
• MalfunctionMar 18, 2019Smoking; Smoking

  IT WAS REPORTED THAT DURING THE POWER ON SELF TEST, THE 980 VENTILATOR WAS OBSERVED TO HAVE SMOKE COMING FROM INSIDE THE UNIT ALONG WITH A BURNT SMELL. THERE WAS NO PATIENT INVOLVEMENT WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8428946 ↗
• DeathJun 25, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT (MVA). THE DATE OF THE MVA WAS NOT SPECIFIED. WHILE THE 980 VENTILATOR WAS IN USE ON THE PATIENT, THE PATIENT¿S SPO2 (SATURATION OF PERIPHERAL OXYGEN) DROPPED BETWEEN 40 ¿ 50 PERCENT. REPORTEDLY, THERE WERE TWO EVENTS, THE FIRST OCCURRING ON (B)(6) 2018 IN WHICH THE PATIENT DESATURATED TO 40 PERCENT AND THE SPECIALIST ANESTHETIST INDICATED THAT THE VENTILATOR MALFUNCTIONED AND SUGGESTED TO CHANGE OUT THE VENTILATOR. HOWEVER, THE SUGGESTION WAS ¿DROPPED¿ AND THE TEAM CARRIED OUT THE NECESSARY TREATMENT AND INCREASED THE FIO2 (FRACTION OF INSPIRED OXYGEN) TO 100 PERCENT. THE PATIENT WAS REPORTED TO HAVE STABILIZED. THE SECOND EVENT OCCURRED ON (B)(6) 2018 IN WHICH THE PATIENT DESATURATED TO 40 PERCENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR (NON-MEDTRONIC DEVICE, E-VENT). THE RESPONSE FROM THE CUSTOMER WAS THAT THE PATIENT DID ¿NOT REALLY¿ STABILIZE AFTER THAT EVENT. ON (B)(6) 2018 THE PATIENT PASSED AWAY. THE PATIENT¿S MEDICAL HISTORY WAS DESCRIBED AS BEING INVOLVED IN A MOTOR VEHICLE ACCIDENT AND THE CAUSE OF DEATH ATTRIBUTED TO ARDS (ACUTE RESPIRATORY DISTRESS SYNDR

  Patient problems: Low Oxygen Saturation

  MAUDE report 7634550 ↗
• MalfunctionDec 12, 2017Fire; Fire

  THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7111227 ↗
• MalfunctionSep 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE 980 VENTILATOR WENT INTO BACKUP VENTILATION. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE DIRECT CURRENT (DC) TO DC CONVERTER. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6892586 ↗
• MalfunctionAug 18, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT A 980 VENTILATOR DID NOT PASS THE POWER ON SELF-TEST (POST) AND GENERATED AN EXHALATION FLOW SENSOR ERROR MESSAGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE PNEUMATIC INTERFACE PRINTED CIRCUIT BOARD AND DOWNLOADED SOFTWARE. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Patient Involvement

  MAUDE report 6805230 ↗
• MalfunctionJun 21, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT, THE BATTERY IN A 980 VENTILATOR WAS NOT CHARGING. 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 REPLACED THE BATTERY. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Patient Involvement

  MAUDE report 6658474 ↗
• MalfunctionJun 13, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT A 980 VENTILATOR FAILED THE POWER ON SELF TEST (POST), THE STATUS DISPLAY WAS NOT WORKING, AND THE GRAPHICAL USER INTERFACE (GUI) TIMED OUT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING THE REPORTED ISSUE.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6636985 ↗
• MalfunctionMay 8, 2017Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT, A 980 VENTILATOR HAD AN ERRATIC GRAPHIC USER INTERFACE (GUI) DISPLAY. 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. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE SE REPLACED THE BACKPLANE PRINTED CIRCUIT BOARD (PCB) AND THE ISSUE WAS RESOLVED.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6551513 ↗