Pneupac 130002VRecalls & reported problems
Icu Medical, Inc. · Class 2
All models of Pneupac (23)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10610586045622), received between Jul 14, 2020 and Mar 29, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (1 report).
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.
Most reported problems
Device problems
- Failure to Align1
- Inaccurate Flow Rate1
- Mechanical Problem1
- Tidal Volume Fluctuations1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE VENTILATOR PRODUCED A HIGH PEEP. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16633236 ↗MalfunctionJul 14, 2020Inaccurate Flow Rate; Tidal Volume Fluctuations; Failure to Align; Inaccurate Flow Rate; Tidal Volume Fluctuations; Failure to Align
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PNEUPAC ACCESSORY TRANSPORT VENTILATOR GAVE HIGH TIDAL VOLUME READINGS ON THE LOWER END. THERE WERE NO REPORTED ADVERSE EFFECTS.
Patient problems: No Information
MAUDE report 10270516 ↗
Other Ventilator, emergency, powered (resuscitator) devices
- Pneupac P310NUSIcu Medical, Inc. · Ventilator, emergency, powered (resuscitator)4 deaths1,035 reports
- 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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