PNEUPAC PARAPAC PLUS
Received Jul 7, 2026 · Event occurred Jun 1, 2026
Report 3012307300-2026-07072 · MDR key 25735566
Device
Generic name
Ventilator, Emergency, Powered (resuscitator)
Manufacturer
Icu Medical Healthcare Manufacturing S.a. De C.vCatalog number
P310NUS
Product problems
- Failure to Cycle
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE HAS STOPPED CYCLING DURING PATIENT USE. THIS CONDITION INDICATES A MALFUNCTION AFFECTING THE DEVICE'S ABILITY TO PROVIDE THE INTENDED RESPIRATORY SUPPORT AND WOULD RESULT IN INTERRUPTION OF THERAPY DELIVERY. THERE WAS REPORTED PATIENT INVOLVEMENT AND NO PATIENT HARM.
Additional Manufacturer Narrative
NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILLED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.