Puritan Bennett 980U1ENASAARecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521201385), received between May 23, 2017 and Jul 17, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “No Flow” (4 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-0342-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHEN SWITCHED ON THIS 980 VENTILATOR WAS NOTED TO HAVE A "BURNING SMELL", A LOUD RATTLING NOISE, AND ON REBOOTING DISPLAYED A "VENTILATOR INOPERATIVE" MESSAGE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535973 ↗
• MalfunctionDec 12, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR GENERATED BACKGROUND FAULT DIAGNOSTIC CODES INDICATING GRAPHICAL USER INTERFACE (GUI) MINOR FAULT, BREATH DELIVERY (BD) MINOR FAULT AND BACKUP VENTILATION (BUV). THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921363 ↗
• MalfunctionJun 25, 2024No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, WHEN THE NURSE WENT TO CHANGE THE MODE FROM SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION (SIMVC+) TO BILEVEL MODE, ON THIS 980 VENTILATOR, THE VENTILATOR TURNED OFF AND IMMEDIATELY TURNED BACK ON IN SERVICE MODE BUT THERE WERE NO BUTTONS TO SELECT, A RED ALARM WAS DISPLAYED WITH NO SOUND. THE BOTTOM SCREEN WAS ALSO OFF. THE SCREEN WAS FROZEN, THEN WENT BLANK AND THEN WENT BLACK. REPORTEDLY, NO VENTILATION WAS OCCURRING AT THIS TIME. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED VIA AN AMBU BAG BEFORE BEING PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY. THE SAFETY VALVE ON THIS VENTILATOR REMAINED OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19611215 ↗
• MalfunctionFeb 8, 2024Improper Flow or Infusion; Improper Flow or Infusion

  UPDATED: IT WAS REPORTED THAT, WHILE IN USE ON A CRITICALLY ILL PATIENT WITH OUT-OF-HOSPITAL VENTRICULAR FIBRILLATION ARREST (OOHVFA), WITH FRACTION OF INSPIRED OXYGEN (FIO2) 0.7 AND NITRIC OXIDE 30 PPM (PARTS PER MILLION) THIS 980 VENTILATOR "STOPPED OPERATING". THE PATIENT WAS UNDER ACUTE DESATURATION AND HAD ASSOCIATED CHANGES IN PARTIAL PRESSURE OF OXYGEN (PAO2) AND OXYGEN SATURATION LEVEL (SAO2) WHICH REQUIRED HAND VENTILATION WITH NITRIC OXIDE, DESATURATION TO OXYGEN SATURATION (SPO2) ~55% WITH 10+ MINUTES OF INTERVENTION TO RETURN TO BASELINE, BEFORE TRANSITIONING TO AN ALTERNATE VENTILATOR AND SUBSEQUENTLY EXPIRED. ALTHOUGH IT WAS REPORTED THAT THE VENTILATOR "STOPPED OPERATING", A REVIEW OF THE VENTILATOR LOGS INDICATES THE DEVICE ENTERED INTO BACKUP VENTILATION (BUV). THE CUSTOMER STATED THAT THEY DO NOT BELIEVE THE DEATH TO BE DEVICE-RELATED AS THE OOHVFA IS CONSIDERED A NON-PREVENTABLE DEATH, EVEN WITH FURTHER TREATMENT.

  Patient problems: Cardiac Arrest; Hypoxia; Low Oxygen Saturation

  MAUDE report 18669133 ↗
• MalfunctionOct 11, 2022No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, WHEN THE NURSING STAFF WERE LOOKING AT ADVANCED VENTILATION SETTINGS ON THIS VENTILATOR THEY PUSHED ON THE NEGATIVE INSPIRATORY FORCE (NIF) MANEUVER TAB. THE VENTILATOR DISPLAY WENT BLANK AND THEN SWITCHED TO SERVICE MODE WITHOUT POWER CYCLING. THE PATIENT DESATURATED TO AS LOW AS 25%. 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 15575842 ↗
• MalfunctionFeb 18, 2022Smoking; Output Problem; Smoking; Output Problem

  IT WAS REPORTED THAT WHILE IN USE ON A VETERINARY PATIENT THIS 980 VENTILATOR GENERATED A DEVICE ALERT. ALTHOUGH PATIENT INTERVENTION DETAILS ARE UNKNOWN THERE WAS NO INJURY TO THE PATIENT. THE DEVICE WAS IN USE AT A VETERINARY FACILITY AND IS NOT APPROVED FOR VETERINARY USE.

  Patient problems: Insufficient Information

  MAUDE report 13563433 ↗
• MalfunctionOct 14, 2021Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR HAD A ¿FAILURE¿. ALTHOUGH REQUESTED, INFORMATION PERTAINING TO PATIENT INTERVENTION AND OUTCOME HAS NOT BEEN PROVIDED. A REVIEW OF THE DIAGNOSTIC LOGS SHOWED THE 980 VENTILATOR ENTERED BACKUP VENTILATION (BUV) AT THE TIME OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 12637007 ↗
• MalfunctionMar 27, 2020No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT, WHEN TURNING ON, A 980 VENTILATOR WAS INOPERATIVE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9892312 ↗
• InjuryMar 13, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT, DURING USE ON A NEONATAL PATIENT, THE ACTUAL PIP (PEAK INSPIRATORY PRESSURE) MEASUREMENT ON A 980 VENTILATOR WAS MORE THAN THE SETTINGS. ACCORDING TO THE ATTENDING PHYSICIAN, THE DELIVERY OF THE HIGH PRESSURE RESULTED IN PATIENT INJURY (BAROTRAUMA). REPORTEDLY, A CHEST TUBE WAS INSERTED INTO THE PATIENT TO REMOVE THE EXCESSIVE AIR. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR.

  Patient problems: High Oxygen Saturation; Tissue Damage

  MAUDE report 7334902 ↗
• MalfunctionFeb 14, 2018Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT, DURING PREVENTATIVE MAINTENANCE, A 980 VENTILATOR FAILED THE BREATH DELIVERY (BD) AUDIO TEST ON AN EXTENDED SELF TEST (EST). THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7270453 ↗
• MalfunctionAug 8, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT, DURING SERVICING, A 980 VENTILATOR HAD A BATTERY FAILURE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE BATTERY. THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Patient Involvement

  MAUDE report 6775703 ↗
• MalfunctionJul 28, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT, DURING SERVICE, THE STATUS DISPLAY ON THE BREATH DELIVERY UNIT (BDU) OF A 980 VENTILATOR WAS BLANK. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) "REBOOTED" THE DEVICE AND THE DISPLAY WAS NO LONGER BLANK. THE SE PLACED THE VENTILATOR ON A TEST LUNG FOR A PERIOD OF TIME AND DID NOT OBSERVE ANOTHER OCCURRENCE OF THE BLANK BDU STATUS DISPLAY. THE VENTILATOR WAS IN WORKING CONDITION.

  Patient problems: No Patient Involvement

  MAUDE report 6752614 ↗
• MalfunctionJul 7, 2017Display or Visual Feedback Problem; Volume Accuracy Problem; Display or Visual Feedback Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT DURING AN EXTENSIVE TESTING OF THE 980 VENTILATOR, MULTIPLE ISSUES WERE FOUND REGARDING THE ACCURACY OF VENTILATION. PER THE CUSTOMER, ¿THE PB980 DOES NOT ACCURATELY DELIVER THE PROGRAMMED VENTILATION¿ AND ¿THE PB980 DOES NOT ACCURATELY REPORT THE DELIVERED VENTILATION.¿ THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6693103 ↗
• MalfunctionJul 7, 2017No Display/Image; Device Displays Incorrect Message; No Display/Image; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING AN EXTENSIVE TESTING OF THE 980 VENTILATOR, 2 ISSUES OCCURRED WHERE THE GRAPHICAL USER INTERFACE (GUI) BECAME BLANK, AND THEN THE VENTILATOR RESTARTED. UPON POWER ON, A SERIAL NUMBER MISMATCH ERROR MESSAGE WAS GENERATED. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6693031 ↗
• MalfunctionJul 7, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING AN EXTENSIVE TESTING OF THE 980 VENTILATOR, MULTIPLE ISSUES WERE FOUND REGARDING THE GRAPHICAL USER INTERFACE (GUI). PER THE CUSTOMER, THE GUI WOULD BECOME BLANK AND/OR RESPONSIVE. IN ADDITION, THE CUSTOMER ALSO REPORTED THAT THE VENTILATOR WOULD OCCASIONALLY RESTART WHEN THE GUI ISSUES OCCURRED. THE CUSTOMER REPORTED THAT THIS ISSUE WAS NORMALLY RESOLVED BY "SWITCHING USB PORTS AND/OR SWAPPING THE USB DEVICE." ONE ISSUE REQUIRED THE VENTILATOR TO BE SHUTDOWN TO RESOLVE THE GUI ISSUE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6692902 ↗
• MalfunctionMay 23, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE. THE SE REPLACED THE UNIVERSAL SERIAL BUS (USB) FLASH DRIVE. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Patient Involvement

  MAUDE report 6586126 ↗
• MalfunctionMay 23, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  THE REPORTED ISSUE OCCURRED DURING SERVICE. 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 6584069 ↗