BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 3238679 · Received July 19, 2013

    Report

    Report Number
    9616091-2013-01269
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Report Date
    July 1, 2013
    Manufacturer
    EMG TECHNOLOGY CO. LTD
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BRAND NAME AS A MECHANICAL (MANUAL) WHEELCHAIR WITH COMMON DEVICE NAME AS 890.3850, PRODUCT CODE AS IOR. MANUFACTURER AS INVAMEX, MODEL NUMBER AS 9XT, SERIAL NUMBER AS (B)(4). INITIAL IMPORTER AS (B)(6). CORRECT BRAND NAME IS PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES; CORRECT COMMON DEVICE NAME IS 868.6250; CORRECT MANUFACTURER IS EMG TECHNOLOGY CO; CORRECT MODEL NUMBER IS IRC1740; SERIAL NUMBER PROVIDED IS (B)(4); CORRECT INITIAL REPORTER IS (B)(6).

    Description of Event or Problem · 1

    PROVIDER STATES UNIT WILL NOT WORK. SERIAL NUMBER ISSUE AS WELL. DEALER STATES THIS IS THE CORRECT SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338604 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI EMG TECHNOLOGY CO. LTD IRC1740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other