Puritan Bennett 980U3ESDIUURecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521201545), received between Jun 7, 2017 and Feb 4, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Inoperable” (3 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-0344-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR HAD A LOSS OF VENTILATION. THE PATIENT WAS MANUALLY VENTILATED USING AN ARTIFICIAL MANUAL BREATHING UNIT (AMBU) BAG. THERE WAS NO INJURY TO THE PATIENT. A REVIEW OF THE VENTILATOR LOGS INDICATE THE VENTILATOR EXPERIENCED A LOSS OF VENTILATION AFTER AN ATTEMPT TO ENTER INTO BACKUP VENTILATION (BUV).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259096 ↗
• MalfunctionNov 12, 2021No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR ¿SHUT DOWN¿. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT WAS IN POOR HEALTH AND DIED LATER DUE TO THEIR "SERIOUS CONDITION". THE HOSPITAL STAFF REPORTED THAT THE VENTILATOR DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804618 ↗
• MalfunctionOct 4, 2021Smoking; Smoking

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR EMITTED SMOKE FROM THE BATTERY AREA AND SHUT DOWN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED VIA AN AMBU BAG BEFORE BEING PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568094 ↗
• MalfunctionJul 26, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT, THE COMPRESSOR ON A 980 VENTILATOR WAS INOPERABLE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED CONDITION. THE SE RECONNECTED ALL OF THE ELECTRICAL CONNECTIONS FROM THE COMPRESSOR AND THE UNIT RESUMED NORMAL OPERATION. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Patient Involvement

  MAUDE report 6745155 ↗
• InjuryJun 7, 2017Device Inoperable; Device Inoperable

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR.

  Patient problems: No Code Available; No Information

  MAUDE report 6620565 ↗
• InjuryJun 7, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT A 980 VENTILATOR WENT INTO INOPERABLE CONDITION AND STOPPED CYCLING WHILE IN USE ON A PATIENT. ALTHOUGH REQUESTED, INFORMATION REGARDING THE INTERVENTION TAKEN ON THE BEHALF OF THE PATIENT HAS NOT BEEN PROVIDED. THE CUSTOMER REPORTED THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Code Available; No Information

  MAUDE report 6620449 ↗