Pneupac 100/905/361Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Pneupac (23)
Data updated Oct 18, 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 15019315079214), received between Apr 12, 2020 and Apr 12, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Decrease in Pressure” (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 18, 2026.
Most reported problems
Device problems
- Decrease in Pressure1
Patient problems
- Asthma1
- Respiratory Distress1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 12, 2020Decrease in Pressure; Decrease in Pressure
INFORMATION RECEIVED A SMITHS MEDICAL VENTILATORS/PNEUPAC VENTILATORS/PNEUPAC DISPOSABLE CIRCUITS MASK SEAL WAS NOT INFLATED SUFFICIENTLY AND COMPLETELY FLAT. A PATIENT WITH ASTHMA WAS NEEDING THE CPAP AND IT WAS IMPOSSIBLE TO CREATE A GOOD SEAL FOR THE DEVICE TO WORK EFFICIENTLY. IN ORDER TO SUPPORT CARE AND AIRWAY CONTROL, THE PATIENT REQUIRED BAG VALVE MASK AIRWAY CONTROL DUE TO CIRCUIT MASK NOT ABLE TO BE IMPLEMENTED. NO LOSS OF AIRWAY CONTROL, AS BAG VALVE MASK WAS EFFICIENT FOR THE INTERIM . THIS WAS A INTERRUPTION IN AIRWAY CONTROL.
Patient problems: Asthma; Respiratory Distress
MAUDE report 9951841 ↗
Other Attachment, breathing, positive end expiratory pressure devices
- N/A 1002Galemed Corporation · Attachment, Breathing, Positive End Expiratory Pressure1 recall1 report
- N/A 1030Galemed Corporation · Attachment, Breathing, Positive End Expiratory Pressure1 recall0 reports
- WaterPAP™ WP-7700Sunmed, LLC · Attachment, Breathing, Positive End Expiratory Pressure1 recall0 reports
- VentStar Resuscitaire CEU MP00310Drägerwerk AG & Co. KGaA · Attachment, Breathing, Positive End Expiratory Pressure1 recall0 reports
- Pneupac 100/905/340-CHIcu Medical, Inc. · Attachment, breathing, positive end expiratory pressure18 reports
- Shiley 125139Covidien LP · Attachment, breathing, positive end expiratory pressure1 death6 reports
- Shiley 125137Covidien LP · Attachment, breathing, positive end expiratory pressure4 reports
- Pneupac 100/905/340Icu Medical, Inc. · Attachment, breathing, positive end expiratory pressure3 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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