BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC¿ PARAPAC PLUS

    MDR report key: 9204939 · Received October 17, 2019

    Report

    Report Number
    3012307300-2019-05686
    Event Type
    Malfunction
    Date Received
    October 17, 2019
    Report Date
    April 7, 2020
    Product Code
    BTL
    UDI-DI
    35019315107263
    PMA / PMN Number
    K123957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ONE PNEUPAC¿ PARAPAC PLUS VENTILATOR WAS RECEIVED WITH NO PHYSICAL DAMAGES. THE VENTILATOR WAS TESTED BY CONNECTING IT TO AN O2 SUPPLY. THE REPORTED ISSUE WAS DUPLICATED; THE GAS EYEBALL INDICATOR DID NOT CHANGE FROM RED TO WHITE. THE ISSUE WAS CAUSED BY A DEFECTIVE OXYGEN GAS SUPPLY INDICATOR. THE OXYGEN GAS SUPPLY PRESSURE INDICATOR KIT WILL BE REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE GAS EYEBALL INDICATOR TO A SMITHS MEDICAL PNEUPAC¿ PARAPAC PLUS WAS OBSERVED TO NOT BE WORKING. THERE WERE NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998409 PNEUPAC¿ PARAPAC PLUS VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL 310 35019315107263

    Patients

    Seq Age Sex Outcome Treatment
    1