Pneupac 100/905/340Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315076107), received between Oct 8, 2018 and Aug 5, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Defective Alarm” (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
- Defective Alarm1
- Gas/Air Leak1
- No Pressure1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2024No Pressure; No Pressure
IT WAS REPORTED THAT THE RELIEF PRESSURE DID NOT INCREASE WHEN PARAPAC PLUS WAS USED ON A PEDIATRIC PATIENT AT THE LOW FLOW SETTING. AFTER HAVING THE PARAPAC PLUS INVESTIGATED IT WAS DETERMINED THAT THE PROBLEM WAS MOST LIKELY ON THE CIRCUIT SIDE. THE EVENT OCCURRED DURING PATIENT USE, NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19911620 ↗MalfunctionOct 24, 2018Gas/Air Leak; Gas/Air Leak
INFORMATION WAS RECEIVED INDICATING THAT A PATIENT WITH A SMITHS MEDICAL PNEUPAC¿ PATIENT CIRCUIT WAS UNABLE TO BE VENTILATED. THE AIR CIRCUIT WAS THEN CHANGED OUT; SOLVING THE PROBLEM. THE FOLLOWING DAY THE EXPIRATORY VALVE WAS NOTED TO BE "STRANGE," CAUSING LEAKAGE OF GAS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8000510 ↗MalfunctionOct 8, 2018Defective Alarm; Defective Alarm
INFORMATION WAS RECEIVED INDICATING THAT DURING VENTILATION OF A PATIENT WITH A SMITHS MEDICAL PNEUPAC¿ PARAPAC PLUS, A CONSTANT LOW PRESSURE ALARM SOUNDED. THE GAUGE ON THE VENTILATOR WAS REPORTED TO SHOW NORMAL VENTILATION PRESSURE. IT WAS NOTED THAT IT WAS THOUGHT TO HAVE BEEN CAUSED BY A LOOSE CAP ON TOP OF THE ONE WAY VALVE OF THE VENTILATOR CIRCUIT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7944614 ↗
Other Attachment, breathing, positive end expiratory pressure devices
- N/A 1002Galemed Corporation · Attachment, Breathing, Positive End Expiratory Pressure1 recall1 report
- VentStar Resuscitaire CEU MP00310Drägerwerk AG & Co. KGaA · Attachment, Breathing, Positive End Expiratory Pressure1 recall0 reports
- WaterPAP™ WP-7700Sunmed, LLC · Attachment, Breathing, Positive End Expiratory Pressure1 recall0 reports
- N/A 1030Galemed Corporation · 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 100/905/360Icu Medical, Inc. · Attachment, breathing, positive end expiratory pressure1 report
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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