BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE E VAC III

    MDR report key: 1626346 · Received January 27, 2010

    Report

    Report Number
    1419185-2009-13085
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Date of Event
    August 24, 2009
    Report Date
    December 22, 2009
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT STATED THAT THE CIRCUIT BOARD ON THE CARE E VAC III PORTABLE SUCTION DEVICE IS FRIED. EVALUATION OF THE RETURNED UNIT IDENTIFIED THAT THE PCB CONTROL BOARD WAS BURNED. 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 CEB071001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other