Pneupac 130002Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586045561), received between Nov 2, 2023 and Nov 2, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Device Difficult to Maintain1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 2, 2023Break; Detachment of Device or Device Component; Device Difficult to Maintain; Break; Detachment of Device or Device Component; Device Difficult to Maintain
IT WAS REPORTED THAT THE FRONT PANEL WAS DAMAGED AND MISSING KNOBS. ADDITIONALLY REQUESTED PREVENTATIVE MAINTENANCE AND EVALUATION. THE CUSTOMER STATED THAT THE OUTCOME OF THE EVENT WAS RESOLVED AND NO FURTHER INFORMATION AVAILABLE. PATIENT INVOLVEMENT UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18059309 ↗
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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