Puritan Bennett 980X1PLDIPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521171619), received between Jun 22, 2017 and Sep 1, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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-0350-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2023Improper Flow or Infusion; Improper Flow or Infusion

  UPDATED: IT WAS REPORTED THAT THIS 980 VENTILATOR GENERATED AN EXHALATION BACKUP VENTILATION MESSAGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 17674054 ↗
• MalfunctionAug 26, 2019No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR GENERATED A ¿BACKGROUND CRASH¿ MESSAGE, THE SCREEN WAS UNRESPONSIVE AND THEN THE VENTILATOR STOPPED WORKING. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. ALTHOUGH REQUESTED, INFORMATION PERTAINING TO PATIENT OUTCOME HAS NOT BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8932315 ↗
• MalfunctionJun 19, 2019Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT A 980 VENTILATOR ENTERED BACK UP VENTILATION WITH THE INSPIRATORY PROPORTIONAL SOLENOID STUCK OPEN AND AN ERROR CODE. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

  Patient problems: No Information

  MAUDE report 8712021 ↗
• MalfunctionSep 5, 2018Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT A 980 VENTILATOR BUTTONS DID NOT WORK AND THE ALARM DID NOT SOUND. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7848694 ↗
• MalfunctionAug 17, 2018No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR HAD A LOSS OF VENTILATION AS IT STOPPED CYCLING AND GENERATED A DEVICE ALERT WITH AN ERROR CODE. 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 7794965 ↗
• MalfunctionNov 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A 980 VENTILATOR WAS SWITCHING INTO BACKUP VENTILATION MODE RANDOMLY. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND 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 7062152 ↗
• MalfunctionAug 24, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE OXYGEN (O2) SENSOR ON A 980 VENTILATOR EXPERIENCED A FAILURE. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE SE REPLACED TO O2 SENSOR. THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Patient Involvement

  MAUDE report 6818777 ↗
• MalfunctionAug 10, 2017Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE OXYGEN (O2) SENSOR ON A 980 VENTILATOR FAILED CALIBRATION. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE SE REPLACED THE O2 SENSOR. THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6785871 ↗
• MalfunctionJul 31, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6754898 ↗
• MalfunctionJul 21, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6732283 ↗
• MalfunctionJul 7, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT, DURING TESTING, A 980 VENTILATOR GENERATED A POWER ON SELF-TEST (POST) ERROR CODE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) EVALUATED THE VENTILATOR AND VERIFIED THE REPORTED ISSUE. THE FLOW VALVE NEEDED TO BE REPLACED. THE EVALUATION AND REPAIR OF THE DEVICE HAS NOT BEEN COMPLETED.

  Patient problems: No Patient Involvement

  MAUDE report 6695119 ↗
• MalfunctionJun 22, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT, A 980 VENTILATOR GENERATED A COMMUNICATION ERROR MESSAGE. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE. THE SE REPLACED THE MEMORY CARD AND PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Information

  MAUDE report 6661296 ↗