BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC PARAPAC VENTILATOR

    MDR report key: 9119750 · Received September 25, 2019

    Report

    Report Number
    3012307300-2019-04995
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Report Date
    April 1, 2020
    Product Code
    BTL
    UDI-DI
    10610586045486
    PMA / PMN Number
    K020899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS COMPLETED ON A A VENTILATORS/PNEUPAC VENTILATORS PARAPAC. THE COMPLAINT OF 02 SUPPLY INDICATOR IS NOT WORKING AND RED WHILE CONNECTED TO OXYGEN NOT VERIFIED NOR VALIDATED AS DEVICE PASSED TESTING. HOSE WAS VISUALLY INSPECTED AND DEVICE PASSED GAS SUPPLY LEAK TEST. ACTION WAS TAKEN AS MORE PREVENTATIVE TO REPLACE GAS SUPPLY INDICATOR ALARM AS A PM. UNKNOWN CAUSE OF EVENT.

    Description of Event or Problem · 0

    INVESTIGATION RESULTS COMPLETED ON A SMITHS VENTILATORS/PNEUPAC VENTILATORS PARAPAC. SUMMARY IN H -10.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PNEUPAC PARAPAC VENTILATOR O2 SUPPLY INDICATOR WAS NOT WORKING, AS IT WAS REPORTED THE INDICATOR "STILL STAYS RED" WHILE CONNECTED TO OXYGEN. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908976 PNEUPAC PARAPAC VENTILATOR VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL 120003 10610586045486

    Patients

    Seq Age Sex Outcome Treatment
    1