BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 3934803 · Received July 15, 2014

    Report

    Report Number
    3008262382-2014-00282
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 10, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

    CAREGIVER STATED THE MACHINE IS NO LONGER MISTING; STATES THE END USER HAS ALREADY MISSED ONE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413308 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI INVACARE REHABILITATION EQUIP IRC1705

    Patients

    Seq Age Sex Outcome Treatment
    1 Other