Puritan Bennett 980U3ENDICURecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10884521171268), received between Feb 1, 2021 and May 8, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (29 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Improper Flow or Infusion; Pressure Problem

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THIS 980 VENTILATOR TRIGGERED A PEAK PRESSURE ALARM WITH THE ALARM SET TO 40 CMH2O. WHEN THE CUSTOMER DECREASED THE PRESSURE CONTROLLED VENTILATION (PCV) FROM 20CMH2O TO 8CMH2O, THE VENTILATOR WAS STILL RESULTING IN PRESSURES ABOVE 40 CMH2O AND IT SOUNDED LIKE THERE WAS A LEAK COMING FROM NEAR THE EXPIRATORY FILTER. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND DURING THE TRANSFER TO AN ALTERNATE VENTILATOR, THE PATIENT DESATURATED WITH A DROP IN BLOOD PRESSURE DUE TO ADDITIONAL SEDATION. REPORTABILITY REASSESSED BASED ON FAILURE ANALYSIS.

  Patient problems: Low Blood Pressure/ Hypotension; Low Oxygen Saturation

  MAUDE report 25124271 ↗
• MalfunctionJul 17, 2025Defective Alarm; Output Problem; Defective Alarm; Output Problem

  IT WAS REPORTED THAT THE 980 VENTILATOR WAS IN AN INOPERATIVE STATUS AT START UP AND GENERATED AN ERROR CODE FOR FAILING THE DIGITAL TO ANALOG CONVERTOR (DAC) TEST DURING THE POWER ON SELF TEST (POST).  ADDITIONALLY, THE VENTILATOR DID NOT PASS BREATH DELIVERY (BD) AUDIO TEST PORTION OF THE EXTENDED SELF TEST (EST). THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532110 ↗
• MalfunctionJan 24, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IR WAS REPORTED THAT THIS 980 VENTILATOR FAILED EXTENDED SELF TEST (EST) WITH AN "INSPIRATORY AUTOZERO SOLENOID NOT OPERATIONAL" MESSAGE. 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 21235574 ↗
• MalfunctionJan 13, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE CIRCUIT PRESSURE TEST PORTION OF SHORT SELF TEST (SST) WITH A "INSPIRATORY AUTOZERO SOLENOID NOT OPERATIONAL" MESSAGE. 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 21144517 ↗
• MalfunctionDec 30, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR DISPLAYED AN "INSPIRATORY AUTOZERO SOLENOID NOT OPERATIONAL" MESSAGE. 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 21041757 ↗
• MalfunctionSep 20, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR DID NOT PASS THE CIRCUIT PRESSURE TEST PORTION OF 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 20269420 ↗
• MalfunctionSep 11, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR GENERATED A VENTILATOR INOPERATIVE MESSAGE. 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 20197195 ↗
• MalfunctionJun 28, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE 980 VENTILATOR GENERATED A "VENT INOP ALARM". THE PATIENT WAS REMOVED FROM THE VEN TILATOR AND PLACED ON AN ALTERNATE VENTILATOR.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634464 ↗
• MalfunctionMar 5, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE SHORT SELF TEST (SST) CIRCUIT PRESSURE TEST. 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 18842039 ↗
• MalfunctionFeb 6, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE SHORT SELF TEST (SST), THE INSPIRATORY AUTO ZERO SOLENOID WAS NOT OPERATIONAL.  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 18655721 ↗
• MalfunctionJan 31, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED CIRCUIT PRESSURE PORTION OF THE SHORT SELF TEST (SST) WITH AN "EXHALATION AUTO ZERO NOT OPERATIONAL" MESSAGE. 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 18619623 ↗
• MalfunctionJan 30, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE CIRCUIT PRESSURE TEST DURING THE SHORT SELF-TEST (SST) WITH AN "EXHALATION AUTO ZERO SOLENOID NOT OPERATIONAL" MESSAGE. 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 18610498 ↗
• MalfunctionJan 16, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT  THIS 980 VENTILATOR GENERATED AN ¿INSPIRATORY AUTO ZERO FAILURE¿ MESSAGE. 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 18522535 ↗
• MalfunctionNov 21, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE CIRCUIT PRESSURE TEST DURING THE EXTENDED SELF-TEST (EST) WITH AN "INSPIRATORY AUTO ZERO SOLENOID NOT OPERATIONAL" MESSAGE. 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 18185084 ↗
• MalfunctionNov 17, 2023No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR GENERATED AN ¿INOPERABLE ALARM". THE PATIENT WAS REMOVED FROM THE VENTILATOR, MANUALLY BAGGED, AND THEN PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY. PER REVIEW OF VENTILATOR LOGS THERE IS EVIDENCE THAT A LOSS OF VENTILATION (LOV) OCCURRED AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18162497 ↗
• MalfunctionNov 6, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED EXTENDED SELF TEST (EST) WITH AN "EXHALATION AUTOZERO SOLENOID NOT OPERATIONAL" MESSAGE. 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 18074411 ↗
• MalfunctionOct 3, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR IS FAILING THE CIRCUIT PRESSURE TEST DURING EXTENDED SELF TEST (EST) WITH AN ¿INSPIRATORY AUTO SOLENOID NOT OPERATIONAL¿ MESSAGE. 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 17862714 ↗
• MalfunctionJul 10, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING SERVICING, THIS 980 VENTILATOR DID NOT PASS THE EXTENDED SELF TEST (EST). 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 17294113 ↗
• MalfunctionJul 10, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE ¿CIRCUIT PRESSURE TEST¿ WITH INSPIRATORY AUTOZERO SOLENOID NOT OPERATIONAL MESSAGE FOR BOTH THE EXTENDED SELF-TEST (EST) AND 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 17293209 ↗
• MalfunctionMay 23, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE SHORT SELF-TEST (SST) WITH AN AUTOZERO SOLENOID ERROR MESSAGE. 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 16989383 ↗
• MalfunctionMay 22, 2023No Flow; No Flow

  IT WAS REPORTED THAT DURING USE THIS 980 VENTILATOR TURNED OFF WHILE PLUGGED INTO ALTERNATING CURRENT (AC). "THE BATTERY INDICATOR WAS FLASHING." THE 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 16978350 ↗
• MalfunctionApr 28, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE SHORT SELF-TEST (SST) CIRCUIT PRESSURE TEST WITH AN "EXHALATION AUTO ZERO SOLENOID NOT OPERATIONAL" ERROR MESSAGE. 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 16839428 ↗
• MalfunctionApr 28, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR GENERATED AN SHORT SELF-TEST (SST) FAILURE DIAGNOSTIC CODE. 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 16838558 ↗
• MalfunctionMar 16, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THIS 980 VENTILATOR "SHUT OFF", THE BREATHS STOPPED BEING DELIVERED AND MEASURED VALUES WERE READING ZERO. THE SCREEN WAS FROZEN WITH VISIBLE RED ALARM. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. ALTHOUGH IT WAS REPORTED THAT THE VENTILATOR SHUTOFF, A REVIEW OF THE VENTILATOR LOGS INDICATE THE VENTILATOR ENTERED INTO BACKUP VENTILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16556284 ↗
• MalfunctionMar 15, 2023Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THIS 980 VENTILATOR'S EXTENDED SELF TEST (EST) AND SHORT SELF TEST (SST) FAILED WITH EXHALATION AUTOZERO SOLENOID NOT OPERATIONAL ERROR. 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 16545554 ↗