BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUSSIONAIRE

    MDR report key: 6962415 · Received October 19, 2017

    Report

    Report Number
    1000524541-2017-00004
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    July 24, 2017
    Report Date
    October 2, 2017
    Manufacturer
    PERCUSSIONAIRE CORP.
    Product Code
    NHJ
    PMA / PMN Number
    K905236
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPV HC IS A HOMECARE THERAPY DEVICE FOR AIRWAY CLEARANCE. THE SUSPECT DEVICE WAS RETURNED TO THE DISTRIBUTOR'S BIOMED TECHNICIAN, WHO COMPLETED THE INVESTIGATION. THE DEVICE WAS INVESTIGATED AND FUNCTIONAL TESTED WITH NO ISSUES NOTED, AND SUBSEQUENTLY RETURNED INTO SERVICE. DURING THE TECHNICIAN'S INVESTIGATION, NO EVIDENCE OF HEAT OR SMOKE WAS FOUND ON OR IN THE DEVICE. THE ONLY ANOMOLIES NOTED WERE THAT THE GRAY OUTER LAYER OF THE POWER CORD INSULATION WAS SHIFTED, AND EXPOSED A BIT MORE OF THE INNER WIRES' INSULATION THAN TYPICAL, THOUGH THE INSULATION ON THE INNER WIRES WAS INTACT, WITH NO COPPER WIRES SHOWING. ALSO, THE FAN GRILLS WERE MISSING, AND THE FILTER CAP WAS MISSING. THIS WAS NOT A REPORTABLE EVENT, BUT WE DECIDED TO FILE THIS MDR SO THAT OUR RESPONSE TO THE END USER'S REPORT WOULD BE ON RECORD.

    Description of Event or Problem · 1

    HOME HEALTH NURSE REPORTED THAT THE DEVICE WAS HOT AND SMOKING, AND THAT THE WIRES ON THE UNIT'S CONNECTOR WERE FRAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743147 PERCUSSIONAIRE IPV HC NHJ PERCUSSIONAIRE CORP. F00012-HT

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR