BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE E VAC III

    MDR report key: 1626198 · Received January 27, 2010

    Report

    Report Number
    1419185-2010-13457
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Date of Event
    November 3, 2009
    Report Date
    January 27, 2010
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT STATED THAT THE UNIT DIDN'T WORK. THE UNIT WAS RETURNED TO OHIO MEDICAL CORPORATION FOR EVALUATION AND REPAIR. THE UNIT WAS EVALUATED BY OHIO MEDICAL CORPORATION REPAIR PERSONNEL AND IDENTIFIED A BURNT SMELL COMING FROM THE UNIT CASING. INSIDE THE UNIT THE CIRCUIT BOARD AND BATTERY WERE FOUND TO BE BURNED/DAMAGED. THE UNIT WAS MAINTAINED FOR EVALUATION BY ENGINEERING AND QA. A REPLACEMENT WAS SENT TO THE CUSTOMER. 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 CEB061045

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other