BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 3073663 · Received April 23, 2013

    Report

    Report Number
    3004493922-2013-00893
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 29, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE COMPRESSOR HAD LOW PSI OUTPUT. THIS ISSUE COULD CAUSE THE USER TO RECEIVE LESS THAN THEIR PRESCRIBED DOSE(S) OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173323 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI INVACARE SUZHOU IRC1705

    Patients

    Seq Age Sex Outcome Treatment
    1 Other