Puritan Bennett 980X1DEDRACRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521171596), received between May 24, 2017 and Jul 5, 2024 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (5 reports).

1 FDA recall record 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 ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT, DURING MAINTENANCE, THIS 980 VENTILATOR FAILED THE LEAK TEST PORTION OF EXTENDED SELF TEST (EST) WITH A "SAFETY VALVE (SV) FAILED TO OPEN" 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 19680339 ↗
• MalfunctionMar 14, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR REQUIRED REPAIR. ALTHOUGH THE REASON FOR REPAIR WAS NOT SPECIFIED, A REVIEW OF THE LOGS SHOW THAT THE VENTILATOR HAD FAILED SHORT SELF TESTING (SST) WITH AN OPEN SAFETY VALVE. THERE WAS NO PATIENT INVOLVEMENT WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18906243 ↗
• MalfunctionJan 26, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE EXHALATION VALVE PRESSURE ACCURACY TEST 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 18591969 ↗
• MalfunctionSep 8, 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) 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 17716016 ↗
• MalfunctionJun 16, 2023Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THIS 980 VENTILATOR SIGNAL LAMPS (VISUAL ALARMS) AT THE TOP OF THE DISPLAY REMAIN OFF. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE DEVICE WAS IN PATIENT USE AT THE TIME OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 17144426 ↗
• MalfunctionMar 24, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR DID NOT PASS THE SHORT AND EXTENDED SELF TEST (SST/EST) WITH MESSAGE ¿INSPIRATORY AUTO ZERO OUT OF RANGE¿. 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 16614143 ↗
• MalfunctionMar 10, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR ¿JUMPED INTO EMERGENCY VENTILATION WITH THE MESSAGE EXTENDED SELF TEST (EST) REQUIRED". THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11454305 ↗
• MalfunctionMar 27, 2020No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT, DURING SERVICING, A 980 VENTILATOR FAILED A POWER ON SELF TEST (POST) WITH A DC (DIRECT CURRENT)- DC CONVERTER FAILURE OUT OF BOX. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9889875 ↗
• MalfunctionAug 2, 2019No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR FAILED. 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 8855798 ↗
• MalfunctionAug 2, 2019No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR FAILED. 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 8855135 ↗
• MalfunctionFeb 15, 2019No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR EXPERIENCED AN UNSPECIFIED FAILURE WITH A BURNT SMELL OBSERVED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM OR INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8345560 ↗
• MalfunctionOct 11, 2018No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR "FAILED" AND GENERATED ERROR CODES. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM OR INJURY.

  Patient problems: No Code Available

  MAUDE report 7958840 ↗
• MalfunctionJul 26, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SCREEN ON A 980 VENTILATOR WAS FAULTY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND THE ISSUE TO BE INTERMITTENT. TO ADDRESS THE ISSUE, THE SE REPLACED THE LIGHT EMITTING DIODE (LED) DISPLAY. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6744526 ↗
• MalfunctionJun 22, 2017Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, A 980 VENTILATOR GENERATED A LOSS OF COMMUNICATION 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 FOUND DIAGNOSTIC CODES RELEVANT TO THE REPORTED INCIDENT RECORDED IN THE VENTILATORS MEMORY LOGS. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Patient Involvement

  MAUDE report 6660416 ↗
• MalfunctionMay 24, 2017Device Inoperable; Device Inoperable

  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 OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE SE REPLACED THE UNIVERSAL SERIAL BUS (USB). THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6589361 ↗