BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE-E-VAC III

    MDR report key: 1856620 · Received September 10, 2010

    Report

    Report Number
    1419185-2010-15279
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 11, 2010
    Report Date
    September 9, 2010
    Manufacturer
    OHIO MEDICAL CORP
    Product Code
    BTA
    PMA / PMN Number
    K062610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OMC AND WAS VISUALLY INSPECTED IN THE "AS FOUND" CONDITION UPON RECEIPT BY A CROSS FUNCTIONAL TEAM REPRESENTING ENGINEERING, EXECUTIVE MGMT, PRODUCTION, AND QUALITY ASSURANCE. THERE WAS NO DAMAGE TO PACKAGING OF RETURNED UNIT, NOR WERE THERE ANY SIGNS OF FURTHER LEAKAGE IN THE PACKAGING. BATTERY ACID WAS NOTED ON INSIDE WALLS OF UNITS HOUSING. TOP RIGHT PORTION OF DEVICE'S ALUMINIUM PLATE BASE SHOWED SIGNS OF DAMAGE/DISCOLORATION. UNIT'S BATTERY WAS INSPECTED. WHAT APPEARED TO BE A DRILL HOLE, UNIFORM OPENING, THREAD IMPRESSIONS WAS OBSERVED IN THE BOTTOM OF UNIT'S BATTERY, NOT A CRACK AS REPORTED BY THE COMPLAINANT. THE HOLE ALIGNED WITH DRILL HOLE AND RUBBER FOOT SCREW WHICH IS LOCATED ON THE BOTTOM OF THE UNIT, STABILIZING THE DEVICE. THERE WAS NO EVIDENCE OF STRIPPED THREADS ON THE SCREW WAS NOTED. THERE WAS NO EVIDENCE OF DRILL HOLE DAMAGE TO THE HOUSING WAS NOTED. THE SCREW PRESENT IN THE RUBBER FOOT DID NOT APPEAR TO BE OVER TIGHTENED. OHIO MEDICAL CORP ATTEMPTED TO SIMULATE THE INCIDENT OF A POTENTIAL DRILLING DEFECT AND WAS ABLE TO DRILL THROUGH HOUSING INTO THE BATTERY HOUSING WHERE THE POINT DRILL HOLES FOR RUBBER FEET WOULD BE ADDED DURING PRE-ASSEMBLY. BASED ON THESE ENGINEERING EVALS, IT IS POSSIBLE THAT BATTERY DAMAGE OCCURRED EITHER BY ASSEMBLY ATTACHING THE FOOT AFTER THE BATTERY HAD BEEN INSTALLED AND SCREWING THE #6 X 1/2" SELF TAPPING SCREW TOO FAR INTO THE HOUSING OR CUSTOMER TURNING THE SCREW INTO THE HOUSING IN AN EFFORT TO TIGHTEN THE RUBBER FOOT. AS A RESULT, THE SELF TAPPING SCREW IS BEING REPLACED WITH A BLUNT END SCREW. OHIO MEDICAL CORP ALSO EXAMINED EXISTING INVENTORY OF THE BATTERY FOR PHYSICAL DAMAGE. NO DAMAGE WAS NOTED. THIS IS THE FIRST SUCH REPORTED INCIDENT OF THIS NATURE.

    Description of Event or Problem · 1

    OMC WAS NOTIFIED BY THE COMPLAINANT, CUSTOMER'S CLINICAL ENGINEER, THAT THE BATTERY INSIDE THE DEVICE WAS LEAKING ACID FROM THE BOTTOM. THE DEVICE HAD BEEN EVALUATED BY THE COMPLAINANT UPON RECEIPT IN (B)(6), 2010 AND IT WAS FUNCTIONING PROPERLY AND AS INTENDED. THE DEVICE WAS NOT BEING USED ON A PT AT THE TIME OF THE OCCURRENCE. THE COMPLAINANT HAD OPENED THE DEVICE HOUSING IN ORDER TO REMOVE THE CANISTER HOLDER AND OBSERVED A SMALL HOLE IN THE BOTTOM OF THE BATTERY. THERE WERE OTHER SIGNS OF LEAKAGE WHICH WERE ALSO VERIFIED BY OMC DURING EVAL OF THE RETURNED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARE-E-VAC III PORTABLE SUCTION DEVICE BTA OHIO MEDICAL CORP CEB101034

    Patients

    Seq Age Sex Outcome Treatment
    1