Puritan Bennett 980X1ENNISBRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10884521171749), received between May 3, 2017 and Jun 20, 2024 — classified as 4 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (5 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-0348-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionJun 20, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR ALARMED "LIMITED MIX CAPABILITY, ONLY 21% OR 100% O2 (OXYGEN) SUPPORTED, PROVIDE ALTERNATE SOURCE OF VENTILATION¿ AND ENTERED INTO BACKUP VENTILATION (BUV). THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19578086 ↗
• MalfunctionSep 23, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR ALARMED WITH "VENTILATOR INOPERATIVE" AND "EXPIRATORY PRESSURE OOR (OUT OF RANGE) 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 15474044 ↗
• MalfunctionJun 3, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THIS 980 VENTILATOR SHUT DOWN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. ALTHOUGH THE CUSTOMER REPORTED VENTILATOR SHUTDOWN, A REVIEW OF SYSTEM DIAGNOSTIC LOGS CONFIRMS THAT THE DEVICE ENTERED INTO BACKUP VENTILATION AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14593839 ↗
• MalfunctionSep 4, 2020Smoking; No Flow; Smoking; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 980 VENTILATOR SHUT DOWN AND HAD A SMOKING/BURNING SMELL. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR AND THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT. DURING EVALUATION OF THE DEVICE, SMOKE WAS FOUND TO BE COMING FROM THE GRAPHICAL USER INTERFACE (GUI) HOUSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10493952 ↗
• MalfunctionJun 7, 2019Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR ALARMED WITH THE MESSAGE: NO OXYGEN DELIVERY AND ENTERED BACK UP VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED VIA AN AMBU BAG BEFORE BEING PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT DE-SATURATED AND THEN RECOVERED WITH NO HARM OR INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 8678354 ↗
• MalfunctionJan 4, 2019No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR SUDDENLY TURNED ITSELF OFF. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED VIA AN AMBU BAG BEFORE BEING PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM OR INJURY.

  Patient problems: No Code Available

  MAUDE report 8217503 ↗
• MalfunctionNov 13, 2018Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT A 980 VENTILATOR BATTERY HAD AN ISSUE CHARGING. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8065869 ↗
• MalfunctionSep 6, 2018Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT A 980 VENTILATOR FAILED THE BREATH DELIVERY (BD) AUDIO TEST PORTION OF THE EXTENDED SELF TEST (EST) AND THE BD ALARM CAPACITOR WAS NOT DISCHARGING. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7850567 ↗
• MalfunctionAug 20, 2018Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT A 980 VENTILATOR FAILED AN EXTENDED SELF TEST (EST) AND GENERATED ERROR CODES WITH THE MESSAGES: "POWER-FAIL CAP NOT DISCHARGING" AND "EXP PRESSURE AUTOZERO OFFSET FAILED." THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7797579 ↗
• MalfunctionApr 30, 2018No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT A 980 VENTILATOR FAILED THE BREATH DELIVERY (BD) AUDIO ALARM ON AN EXTENDED SELF TEST (EST) AND GENERATED ERROR CODE ¿POWER FAIL CAP NOT DISCHARGING¿. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7474008 ↗
• MalfunctionNov 27, 2017No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT A 980 VENTILATOR HAD AN INTERMITTENT FAULT WITH THE BREATH DELIVERY AUDIO TEST. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7062092 ↗
• InjuryAug 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR HAD "STOPPED READING TIDAL VOLUME" AND WAS "STORING THE EXHALATION CALIBRATION". 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. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED EVENT. THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Code Available

  MAUDE report 6767989 ↗
• MalfunctionAug 2, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT A 980 VENTILATOR GENERATED A CONSTANT ALARM. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. 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 EXHALATION VALVE FLOW SENSOR (EVQ) AND BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6760640 ↗
• InjuryJul 26, 2017Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT THE SCREEN ON A 980 VENTILATOR RESET AND THEN BECAME ERRATIC. 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 EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND WAS NOT ABLE TO DUPLICATE THE REPORTED CONDITION. THE VENTILATOR WAS RUN ON A TEST LUNG FOR 48 HOURS WITHOUT INCIDENT. THE VENTILATOR PASSED EXTENDED SELF-TESTING AND NO PARTS WERE REPLACED.

  Patient problems: No Code Available

  MAUDE report 6745054 ↗
• MalfunctionJul 17, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  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 6718270 ↗
• InjuryJul 17, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR BEGAN ALARMING. 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. REPORTEDLY, THE VENTILATOR ALSO DISPLAYS RED MESSAGES AND ALARMS WHEN "SWITCHED ON". 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 EXHALATION SENSOR PRINTED CIRCUIT BOARD (PCB). THE VENTILATOR PASSED ALL TESTING.

  Patient problems: No Code Available

  MAUDE report 6718072 ↗
• MalfunctionJul 11, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT, DURING SERVICE, A 980 VENTILATOR GENERATED A SERIAL NUMBER MISMATCH ERROR MESSAGE. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SE REPLACED THE BREATH DELIVERY (BD) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB) AND UPDATED THE SOFTWARE. THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Patient Involvement

  MAUDE report 6702415 ↗
• MalfunctionJul 11, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SMALL SCREEN ON A 980 VENTILATOR WAS BLANK. REPORTEDLY, THE CUSTOMER "RE-BOOTED" THE DEVICE AND THE SCREEN WAS WORKING. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6701540 ↗
• MalfunctionJun 2, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT A 980 VENTILATOR BATTERY WOULD NOT CHARGE AND GENERATED A BATTERY ERROR MESSAGE. THERE WAS NO PATIENT HARM REPORTED AT THE TIME OF THE EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND A DIAGNOSTIC CODES IN THE MEMORY LOGS RELEVANT TO THE REPORTED ISSUE. THE SE REPLACED THE BATTERIES.

  Patient problems: No Information

  MAUDE report 6608292 ↗
• MalfunctionMay 30, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING INSTALLATION A 980 VENTILATOR BATTERY WOULD NOT CHARGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE. THE SE REPLACED THE POWER CONTROLLER AND POWER DISTRIBUTION BOARD (PCB) AND PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Patient Involvement

  MAUDE report 6598929 ↗
• MalfunctionMay 24, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT A 980 VENTILATOR BATTERY FAILED. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Information

  MAUDE report 6589289 ↗
• MalfunctionMay 24, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT A 980 VENTILATOR BATTERY FAILED. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND A DIAGNOSTIC CODE RELEVANT TO THE REPORTED INCIDENT RECORDED IN THE VENTILATORS MEMORY LOGS AND VERIFIED THE REPORTED ISSUE. THE SE REPLACED THE BATTERY. THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Information

  MAUDE report 6588438 ↗
• MalfunctionMay 17, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT, A 980 VENTILATOR GENERATED AN EXHALATION FLOW SENSOR ERROR MESSAGE. ALTHOUGH REQUESTED, IT IS UNKNOWN IF A PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Information

  MAUDE report 6571833 ↗
• MalfunctionMay 9, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT A 980 VENTILATOR BATTERY DOES NOT CHARGE. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE SE REPLACED THE POWER DISTRIBUTION BOARD PRINTED CIRCUIT BOARD (PCB) AND THE POWER CONTROLLER PCB. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Patient Involvement

  MAUDE report 6555034 ↗
• InjuryMay 3, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT, DURING USE ON A PATIENT, THE UPPER SCREEN ON A 980 VENTILATOR WENT BLANK. THE VENTILATOR CONTINUED TO VENTILATE THE PATIENT, AND LATER, THE BLANK SCREEN REOCCURRED. 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. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND A DIAGNOSTIC CODE IN THE MEMORY LOGS, HOWEVER, THE REPAIR OF THE DEVICE HAS NOT BEEN COMPLETED.

  Patient problems: No Code Available

  MAUDE report 6542023 ↗