Puritan Bennett 980U1PTDIUNARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521201439), received between Apr 27, 2020 and Jan 3, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (2 reports).

2 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR ENTERED INTO BUV (BACK UP VENTILATION). 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 16091090 ↗
• MalfunctionFeb 1, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR DISPLAYED ¿LIMITED MIX CAPACITY¿ MESSAGE AND SHUT DOWN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM OR INJURY. ALTHOUGH THE CUSTOMER REPORTED THAT THE VENTILATOR ¿SHUT DOWN¿ REVIEW OF THE VENTILATOR LOGS INDICATE THE VENTILATOR ENTERED BACK UP VENTILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11259258 ↗
• MalfunctionJun 18, 2020No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR STOPPED CYCLING, SHUT DOWN WITH A LOSS OF VENTILATION AND A BLACK SCREEN. 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 10171534 ↗
• MalfunctionApr 27, 2020Smoking; Smoking

  IT WAS REPORTED THAT A 980 VENTILATOR HAD SMOKE COME OUT FROM BEHIND THE MONITOR. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 10002827 ↗