BEUDAMED
    FDA Adverse Event Other Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 2026796 · Received March 17, 2011

    Report

    Report Number
    1525712-2011-00107
    Event Type
    Other
    Date Received
    March 17, 2011
    Date of Event
    April 30, 2009
    Report Date
    March 16, 2011
    Manufacturer
    EMG
    Product Code
    BTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY IS REPORTED. CONSUMER ALLEGED, THE ASPIRATOR WAS NOT WORKING. DEALER STATED THERE WAS A BURNT SMELL AND NOTICED BLACK MARKS. UNCLEAR IF DEVICE WAS DROPPED. ELECTRONIC MALFUNCTIONS WITHIN THE ASPIRATOR, INCLUDING ANY DEBRIS THAT MAY RESULT, ARE WELL CONTAINED WITHIN THE METAL ENCLOSURE OF THE DEVICE. PRODUCT HAS NOT BEEN RETURNED FOR EVAL SO, IT IS UNK IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. PRODUCT WAS APPROXIMATELY 2 YEARS OLD AT TIME OF INCIDENT WITH NO PREVIOUS COMPLAINTS. DEALER HAS BEEN CONTACTED SEVERAL TIMES FOR RETURN OF PRODUCT FOR AN EVAL. DEALER HAS NOT RESPONDED. MDR FILED SOLELY ON DEALER'S STATEMENT OF A BURNT SMELL.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES, THE MACHINE WAS NOT WORKING. THE DEALER STATES WHEN SHE PICKED UP THE UNIT, THERE WAS A BURNT SMELL AND THE UNIT HAD BLACK MARKS. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI EMG IRC1135

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR