BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 4241694 · Received November 10, 2014

    Report

    Report Number
    3008262382-2014-01931
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 23, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES UNIT HAS POWER BUT NO OUTPUT. DEALER NOT PROVIDING END USER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723160 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI INVACARE REHABILITATION EQUIP IRC1705

    Patients

    Seq Age Sex Outcome Treatment
    1 Other