BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 2921183 · Received January 17, 2013

    Report

    Report Number
    3004493922-2013-00135
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    AN INITIAL REPORT WAS RECEIVED. HOWEVER, HAVE ATTEMPTED TO GATHER ADDITIONAL INFORMATION AND CLARIFY INCIDENT. MDR FILED SINCE THE END USER MAY POSSIBLY BE UNABLE TO USE THE DEVICE FOR ADMINISTRATION OF MEDICATION HOWEVER HAS NOT BEEN CONFIRMED. IT WAS REPORTED NO INJURY OCCURRED. PLEASE NOTE: ANY FURTHER INFORMATION RECEIVED WILL BE FILED IN A SUPPLEMENTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25766 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI INVACARE SUZHOU IRC1705

    Patients

    Seq Age Sex Outcome Treatment
    1 Other