BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE E VAC III

    MDR report key: 1484714 · Received July 27, 2009

    Report

    Report Number
    1419185-2009-12796
    Event Type
    Malfunction
    Date Received
    July 27, 2009
    Date of Event
    July 7, 2009
    Report Date
    July 27, 2009
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT REPORTED ON 07/07/09 THAT THE BATTERY FOR THE CARE E VAC III UNIT WOULD NOT CHARGE AND THERE WAS AN ELECTRICAL BURNING SMELL COMING FROM THE UNIT. THE SUBJECT UNIT WAS RETURNED TO OHIO MEDICAL CORPORATION FOR EVALUATION. UNIT (B)(4) WAS RECEIVED BY OHIO MEDICAL CORPORATION ON 07/08/09 AND WAS EVALUATED BY THE REPAIR CENTER ON 07/20/09. EVALUATION OF THE RETURNED UNIT (B)(4) SHOWED THAT THE UNIT WOULD NOT POWER ON. WHEN THE UNIT WAS OPENED, THE INSIDE OF THE CASING AND ELECTRICAL COMPONENTS (CIRCUIT BOARD) WERE CHARRED AND BURNED. THE UNIT WAS REPAIRED, RECERTIFIED PER SPECIFICATION (B)(4) AND RETURNED TO THE CUSTOMER. THE UNIT WAS FURTHER EVALUATED BY ENGINEERING PERSONNEL. 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

    COMPLAINANT STATED THAT THE BATTERY ON THE CARE E VAC III PORTABLE SUCTION DEVICE WAS NOT CHARGING. THE UNIT HAD AN ELECTRICAL BURNING SMELL COMING FROM IT. EVALUATION OF THE RETURNED UNIT IDENTIFIED THAT THE PCB CONTROL BOARD WAS BURNED, CAUSING THE UNIT TO NOT POWER ON. 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 CEB081036

    Patients

    Seq Age Sex Outcome Treatment
    1 Other