BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUCTION APPARATUS, PATIENT CARE

    MDR report key: 2026787 · Received March 17, 2011

    Report

    Report Number
    1525712-2011-00114
    Event Type
    Other
    Date Received
    March 17, 2011
    Date of Event
    September 23, 2009
    Report Date
    March 16, 2011
    Manufacturer
    EMG TECHNOLOGY CO. LTD
    Product Code
    BTA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY IS REPORTED. CONSUMER ALLEGED, THE OBSERVED SMOKE. IT IS NOT KNOWN IF THE DEVICE WAS DROPPED. ELECTRONIC MALFUNCTIONS WITHIN THE ASPIRATOR, INCLUDING ANY DEBRIS THAT MAY RESULT, ARE WELL CONTAINED WITHIN THE METAL ENDOSURE OF THE DEVICE. DEVICE IS EARTH GROUND. PRODUCT HAS NOT BEEN RETURNED FOR EVAL; IT IS UNK IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MALFUNCTION NOT CONFIRMED. DEALER HAS BEEN CONTACTED FOR RETURN OF PRODUCT FOR AN EVAL. DEALER HAS NOT RESPONDED. MDR FILED SOLELY ON CONSUMER'S STATEMENT OF OBSERVING SMOKE.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES, THE UNIT STARTED SMOKING AND THEN THEY UNPLUGGED THE UNIT. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION APPARATUS, PATIENT CARE 870.5050 BTA EMG TECHNOLOGY CO. LTD IRC1135

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR