Puritan Bennett 980X3ENDIJIRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521172821), received between Aug 8, 2017 and Jun 20, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “No Flow” (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 16, 2026.

Recalls naming this device

1. Mar 25, 2022Open, 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, 2020Open, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Device Emits Odor; No Flow; Device Emits Odor; No Flow

  IT WAS REPORTED THAT, WHEN POWERED UP, THIS 980 VENTILATOR HAD A BURNT SMELL. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. EVALUATION OF THE VENTILATOR BY SERVICE PERSONNEL IDENTIFIED THERMAL DAMAGE OF THE DIRECT CURRENT (DC)-DC CONVERTER PRINTED CIRCUIT BOARD ASSEMBLY (PCBA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298238 ↗
• MalfunctionNov 16, 2023Smoking; Smoking

  IT WAS REPORTED THAT, DURING INSTALLATION OF THIS 980 VENTILATOR BY THE FIELD SERVICE ENGINEER (FSE) SMOKE WAS SEEN COMING FROM THE SCREEN. 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 18151598 ↗
• MalfunctionOct 28, 2021Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR GENERATED A VISUALLY ANNUNCIATED ALARM, HOWEVER HAD NO AUDIBLE SOUND. 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 12715837 ↗
• MalfunctionAug 21, 2020No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR STOPPED WORKING AND GENERATED AN ALARM ¿TO REPLACE THE VENTILATOR".

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10440377 ↗
• MalfunctionAug 8, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE DISPLAY ON A 980 VENTILATOR WAS BLANK. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE EVALUATION AND REPAIR OF THE DEVICE HAS NOT BEEN COMPLETED.

  Patient problems: No Patient Involvement

  MAUDE report 6774410 ↗