Puritan Bennett 980X1FRAIQCRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521171732), received between Jul 20, 2017 and Jan 29, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THIS 980 VENTILATOR GENERATED AN ALARM AND ENTERED INTO BACKUP VENTILATION (BUV). THERE WAS NO PATIENT INJURY. A REVIEW OF THE VENTILATOR LOGS SHOW BUV WAS ENTERED AFTER AN EXTENDED PERIOD OF VENTILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211248 ↗
• MalfunctionApr 27, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR GENERATED AN 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 16825402 ↗
• 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 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 16264975 ↗
• MalfunctionApr 27, 2020No Flow; No Flow

  ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: THE PATIENT'S OXYGEN SATURATIONS RETURNED TO BASELINE QUICKLY AFTER THE EVENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 10002716 ↗
• MalfunctionApr 22, 2020No Flow; No Flow

  IT WAS REPORTED THAT, DURING USE ON A PATIENT THE PB980 VENTILATOR STOPPED CYCLING WITH ALARM. IT WAS ALSO NOTED THAT THE PATIENT OXYGEN SATURATION WAS AT 50%. PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 9988683 ↗
• MalfunctionJul 25, 2018Display or Visual Feedback Problem; No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, WHEN A 980 VENTILATOR WAS USING THE QUICK START VENTILATION MODE, THE PATIENT WAS NOT VENTILATED BECAUSE OF THE NON-PHYSIOLOGICAL DEFAULT SETTINGS OF THE VENTILATOR. REPORTEDLY, THE RESPIRATORY FREQUENCY, INSPIRATORY TIME, AND I:E (INSPIRATORY/EXPIRATORY) RATIO WERE NOT ADAPTED TO THE PRECONFIGURED INSTITUTIONAL VOLUME SETTINGS. REPORTEDLY, THE INSPIRATORY TIME WAS TOO SHORT AND THE PRESSURE ALARM LIMIT WAS REACHED IMMEDIATELY. ALTHOUGH REQUESTED, INFORMATION PERTAINING TO PATIENT INTERVENTION AND OUTCOME (IF APPLICABLE) HAS NOT BEEN PROVIDED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7721026 ↗
• MalfunctionJul 2, 2018Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT WITH ACUTE RESPIRATORY INSUFFICIENCY, A 980 VENTILATOR HAD A LOSS OF VENTILATION AS THE DEVICE "DIDN'T START THE NONINVASIVE MECHANICAL VENTILATION (PRESSURE SUPPORT VENTILATION PSV-MODE) AFTER HAVING CONNECTED THE VENTILATOR TO THE PATIENT.¿ IT WAS REPORTED THAT UNSPECIFIED SUPPLEMENT TREATMENT WAS REQUIRE, ALTHOUGH MECHANICAL VENTILATION INITIATED AND THE PATIENT DID NOT REQUIRE A TRANSFER TO ANOTHER VENTILATOR.

  Patient problems: No Information

  MAUDE report 7657264 ↗
• MalfunctionJul 20, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT A 980 VENTILATOR FAILED THE POWER ON SELF-TEST (POST) AND GENERATED A DIAGNOSTIC 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, REPLACED THE BREATH DELIVERY (BD) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB), AND INSTALLED SOFTWARE. THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Patient Involvement

  MAUDE report 6730445 ↗
• MalfunctionJul 20, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT A 980 VENTILATOR FAILED THE POWER ON SELF TEST (POST) AND GENERATED A DIAGNOSTIC ERROR MESSAGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE CUSTOMER REPORTED THAT THEY PERFORMED EXTENDED SELF-TESTING (EST).

  Patient problems: No Patient Involvement

  MAUDE report 6730295 ↗