BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUSSIONAIRE

    MDR report key: 7937752 · Received October 5, 2018

    Report

    Report Number
    7937752
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    September 16, 2018
    Report Date
    September 28, 2018
    Manufacturer
    PERCUSSIONAIRE CORPORATION
    Product Code
    NHJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IPV UNIT CEASED "PULSATILE" FUNCTION. UNIT ONLY BLOWS CONTINUOUS STREAM OF AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779873 PERCUSSIONAIRE DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT NHJ PERCUSSIONAIRE CORPORATION F00001-C

    Patients

    Seq Age Sex Outcome Treatment
    1 15695 DA