BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 1973030 · Received January 20, 2011

    Report

    Report Number
    1525712-2011-00021
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    October 1, 2010
    Report Date
    January 20, 2011
    Manufacturer
    MEDEL S.P.A.
    Product Code
    BTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER ALLEGES THEY RECEIVED A SHOCK FROM THEIR UNIT. NO INJURY IS REPORTED AND THE DEALER HAS REPLACED THE DEVICE. NO MODEL OR SERIAL NUMBER HAS BEEN PROVIDED. DEVICE CONDITION AND USE HISTORY IS UNKNOWN. IT IS NOT KNOWN IF DEVICE HAD BEEN DROPPED OR DAMAGED PRIOR TO THE ALLEGED INCIDENT. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED BASED ON ALLEGED SHOCK.

    Description of Event or Problem · 1

    THE CONSUMER STATES SHE WAS GETTING READY TO TURN THE UNIT OFF AFTER HER TREATMENT, WHEN SHE WAS ALLEGEDLY SHOCKED BY THE UNIT. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI MEDEL S.P.A. STRATOS

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR