Puritan Bennett 980S3ENDICURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521171244), received between Oct 1, 2018 and May 22, 2023 — classified as 4 malfunctions.

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

3 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. 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-0341-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

3. 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.

• MalfunctionMay 22, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE EXTENDED SELF TEST (EST) AND 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 16975944 ↗
• MalfunctionMar 10, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED WHILE IN USE ON A PATIENT THAT THIS (B)(4) VENTILATOR CONTINUED TO ALARM, WAS UNABLE TO SILENCE ALARM, AND WENT INTO BUV (BACKUP VENTILATION). PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13722449 ↗
• MalfunctionAug 29, 2019No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR WENT INTO AN INOPERATIVE CONDITION AND GENERATED A BACKGROUND ERROR CODE. ALTHOUGH REQUESTED, INFORMATION PERTAINING TO PATIENT INTERVENTION AND OUTCOME HAS NOT BEEN PROVIDED.

  Patient problems: No Information

  MAUDE report 8945631 ↗
• MalfunctionOct 1, 2018No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR HAD AN OCCLUSION, A "LARGE CRASHING SOUND FROM INSIDE THE VENTILATOR" AND WOULD NOT VENTILATE THE PATIENT. REPORTEDLY, AS THE PATIENT WAS BEING REPOSITIONED, THE PATIENT WAS COUGHING. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED VIA AN AMBU BAG BEFORE BEING PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Code Available

  MAUDE report 7922961 ↗