BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE E VAC III

    MDR report key: 1626347 · Received January 27, 2010

    Report

    Report Number
    1419185-2010-11536
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Date of Event
    December 4, 2008
    Report Date
    January 27, 2010
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT WAS NOT CERTAIN WHAT WAS WRONG WITH THE UNIT AND RETURNED IT TO OHIO MEDICAL CORPORATION FOR WARRANTY REPAIR. THE DEVICE WAS RECEIVED AND EVALUATED BY OHIO MEDICAL CORPORATION REPAIR PERSONNEL AND FOUND THAT THE CIRCUIT PANEL WAS BURNED, THE WIRES WERE DAMAGED AND THERE WAS EVIDENCE OF SMOKE RESIDUE (SOOT) INSIDE THE CASING OF THE UNIT. THIS EVENT DID NOT CONTRIBUTE TO A DEATH, ILLNESS OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARE E VAC III PORTABLE SUCTION DEVICE BTA OHIO MEDICAL CORPORATION 3 CEB061078

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other