BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE E VAC III

    MDR report key: 1484713 · Received July 27, 2009

    Report

    Report Number
    1419185-2009-12605
    Event Type
    Malfunction
    Date Received
    July 27, 2009
    Report Date
    July 27, 2009
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    BTA
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT REPORTED ON (B)(6) 09 THAT THE INSIDE OF THE CARE E VAC III UNIT STARTED ON FIRE. THE SUBJECT UNIT WAS RETURNED TO OHIO MEDICAL CORPORATION FOR EVALUATION. UNIT (B)(4) WAS RECEIVED BY OHIO MEDICAL CORP ON 06/11/09 AND WAS EVALUATED BY THE REPAIR CENTER ON 06/11/09. EVALUATION OF THE RETURNED UNIT (B)(4) SHOWED THAT THE UNIT WOULD NOT POWER ON AND IT SMELLED BURNT. WHEN THE UNIT WAS OPENED, THE INSIDE OF THE CASING AND ELECTRICAL COMPONENTS (CIRCUIT BOARD) WERE CHARRED AND BURNED. AS A RESULT OF THE DAMAGE TO THE UNIT, THE REPAIR CENTER RECOMMENDED THAT THE UNIT BE SCRAPPED INSTEAD OF REPAIRED. THE UNIT WAS FURTHER EVALUATED BY ENGINEERING PERSONNEL. THE EXACT CAUSE OF THE FIRE AT THE TIME OF THE INITIAL REPORT IS UNK. THE INVESTIGATION IS CURRENTLY ONGOING.

    Description of Event or Problem · 1

    THE INSIDE OF THE UNIT WAS ON FIRE PER THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARE E VAC III PORTABLE SUCTION DEVICE BTA OHIO MEDICAL CORPORATION 3 CEB071115

    Patients

    Seq Age Sex Outcome Treatment
    1 Other