BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 2993411 · Received March 7, 2013

    Report

    Report Number
    3004493922-2013-00543
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 11, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE MEDICINE CUP/APPLICATOR IS CRACKED WHICH MAY AFFECT THE CONSUMER'S ABILITY TO RECEIVE A FULL DOSE OF PRESCRIBED MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97702 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI INVACARE SUZHOU IRC1705

    Patients

    Seq Age Sex Outcome Treatment
    1 95 Other