BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE E VAC III

    MDR report key: 1691664 · Received May 3, 2010

    Report

    Report Number
    1419185-2010-14126
    Event Type
    Malfunction
    Date Received
    May 3, 2010
    Date of Event
    February 23, 2010
    Report Date
    May 3, 2010
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE EVALUATION AND INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE COMPLAINANT STATED THAT THE CIRCUIT BOARD ON THE UNIT WAS BURNT. THE UNIT WAS RETURNED TO OHIO MEDICAL CORPORATION FOR EVALUATION AND REPAIR. THE UNIT WAS KEPT FOR FURTHER EVALUATION BY ENGINEERING AT OHIO MEDICAL CORPORATION. A REPLACEMENT UNIT 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 CEB071071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other