BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC

    MDR report key: 10106087 · Received June 1, 2020

    Report

    Report Number
    3012307300-2020-05372
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Report Date
    July 21, 2020
    Product Code
    BTL
    UDI-DI
    10610586045486
    PMA / PMN Number
    K020899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE VENTILATOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE FOUND THE BATTERY HOLDER CORRODED. DEVICE UNDERWENT THE NRV ENTRAINMENT TESTING FOR AIR MIX. THE REPORTED CUSTOMER COMPLAINT WAS CONFIRMED AS THE DEVICE HAD FAILED THE TESTING DUE TO A FAULTY VARIABLE RELIEF VALVE ASSEMBLY. HOWEVER, THE PROBLEM SOURCE HAS BEEN DETERMINED TO BE UNKNOWN.

    Description of Event or Problem · 0

    RO 1065934: HIGH PRESSURE ALARM KEEPS ALARMING. ADDITIONAL INFORMATION RECEIVED 15 MAY 2020: NO PATIENT INVOLVEMENT. DEVICE WAS ACTIVATED DURING A TEST AND AN ALARM WAS ACTIVATED. RMA# 250958.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT HIGH PRESSURE ALARMS CONTINUALLY OCCURRED TO A SMITHS MEDICAL PNEUPAC PARAPAC VENTILATOR DURING TESTING. THERE WERE NO PATIENT INVOLVEMENT OR ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569674 PNEUPAC VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL 120003 10610586045486

    Patients

    Seq Age Sex Outcome Treatment
    1