BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE E VAC III

    MDR report key: 1484715 · Received July 27, 2009

    Report

    Report Number
    1419185-2009-10076
    Event Type
    Malfunction
    Date Received
    July 27, 2009
    Report Date
    July 27, 2009
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT REPORTED ON 04/28/2008 THAT THE CARE E VAC III UNIT SMELLS LIKE SMOKE AND BURN MARKS WERE IDENTIFIED ON THE CIRCUIT BOARD WHERE THE PUMP WIRES ATTACH. THE SUBJECT UNIT WAS RETURNED TO OHIO MEDICAL CORP FOR EVAL. UNIT (B)(4) WAS RECEIVED BY OHIO MEDICAL CORP ON 04/28/2008 AND WAS EVALUATED BY THE REPAIR CENTER ON 05/01/2008. EVAL OF THE RETURNED UNIT (B)(4) SHOWED THAT THE INSIDE OF THE HOUSING AND ELECTRICAL COMPONENTS (CIRCUIT BOARD) WERE CHARRED AND BURNED. THE UNIT WAS REPAIRED, RECERTIFIED PER SPEC (B)(4) AND RETURNED TO THE CUSTOMER. THIS INCIDENT IS UNDER FURTHER EVAL UNDER COMPLAINT (B)(4). THE EXACT CAUSE OF THE INCIDENT AT THE TIME OF THIS INITIAL REPORT IS UNK. THE INVESTIGATION IS CURRENTLY ONGOING.

    Description of Event or Problem · 1

    THE COMPLAINANT STATED THAT THEY COULD SMELL SMOKE COMING FROM THE UNIT. THE BOARD HAS BURN MARKS WHERE THE WIRES FROM THE PUMP ATTACH TO THE CIRCUIT BOARD. THE UNIT WAS RETURNED FOR EVAL TO OHIO MEDICAL CORP ON 04/28/2008. THE CIRCUIT BOARD, HOUSING, LABELING, AND BATTERY WERE BURNED AND DAMAGED BEYOND REPAIR. THE DAMAGED COMPONENTS WERE REPLACED AND THE UNIT WAS REPAIRED, RECERTIFIED, AND RETURNED TO THE CUSTOMER ON 05/01/2008.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other