Pneupac VR1AIRNUSRecalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 35019315074862), received between Nov 15, 2023 and Mar 31, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak2
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Cardiac Arrest1
- Cyanosis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE DEVICE HAD AIR LEAKING. THERE WERE NO PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21734520 ↗MalfunctionAug 22, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE PRODUCT HAS A GAS LEAK AND SPO2 DOESN'T INCREASE EVEN IT IS CONNECTED. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARMED REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20032979 ↗InjuryNov 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT WENT INTO CARDIOPULMONARY ARREST DURING USE. "PREVIOUSLY USED VR1 WHEN TAKING A BATH". WHEN A CT SCAN WAS PERFORMED, THE PATIENTS FACE TURNED BROWN AND CYANOSIS WAS CONFIRMED, AND WENT INTO CARDIOPULMONARY ARREST. THE PATIENT WAS IMMEDIATELY RESUSCITATED BY ADMINISTERING CARDIAC MASSAGE AND ELECTRIC SHOCK, AND RETURNED TO THE WARD AND PUT ON A VENTILATOR. THEN AT 11:30 THE PATIENT HAD THE SAME SYMPTOMS AGAIN. THE SECOND TIME, THE PATIENT WAS NOT USING VR1, SO THE REPORTER BELIEVES IT TO BE AN ISSUE WITH THE PATIENT. THE PATIENT'S CONDITION HAS SINCE STABILIZED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Cardiac Arrest; Cyanosis
MAUDE report 18144061 ↗
Other Ventilator, emergency, powered (resuscitator) devices
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- Pneupac 120003Icu Medical, Inc. · Ventilator, emergency, powered (resuscitator)2 deaths523 reports
- Neo-Tee T-Piece Resuscitator 10-50805Mercury Enterprises, Inc. · Ventilator, Emergency, Powered (Resuscitator)3 recalls0 reports
- Neo-Tee T-Piece Resuscitator 10-50811Mercury Enterprises, Inc. · Ventilator, Emergency, Powered (Resuscitator)2 recalls3 reports
- Neo-Tee T-Piece Resuscitator 10-50809Mercury Enterprises, Inc. · Ventilator, Emergency, Powered (Resuscitator)2 recalls0 reports
- Neo-Tee T-Piece Resuscitator 10-50810Mercury Enterprises, Inc. · Ventilator, Emergency, Powered (Resuscitator)2 recalls0 reports
- Neo-Tee T-Piece Resuscitator 10-50832Mercury Enterprises, Inc. · Ventilator, Emergency, Powered (Resuscitator)2 recalls0 reports
- Neo-Tee T-Piece Resuscitator 10-50808Mercury Enterprises, Inc. · Ventilator, Emergency, Powered (Resuscitator)2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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