BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIMAGE GAMMA CAMERA SYSTEM

    MDR report key: 2974305 · Received December 19, 2012

    Report

    Report Number
    9616576-2012-00003
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 27, 2012
    Report Date
    December 18, 2012
    Manufacturer
    DDD-DIAGNOSTIC A/S
    Product Code
    KPS
    PMA / PMN Number
    K081829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: A REDUCTION OF THE RISK PRODUCT FROM 18 TO 9 WILL EFFICIENTLY REDUCE THE POTENTIAL HAZARD FOR FIRE FOR ALL AFFECTED UNITS WHICH IS WHY (B)(4) DO NOT PLAN FOR FURTHER RISK REDUCTION MEASURES TO BE INITIATED IN RELATION TO THIS INCIDENT. BASED ON THE SITE INSPECTIONS AND THE INSPECTION OF THE FAILING BATTERY PERFORMED BY THE DEVICE DISTRIBUTOR (B)(6) IT HAS BEEN CONFIRMED THAT THE CAUSE TO THE INCIDENT FAILURE WAS AN INTERNAL SHORT IN ONE OF THE BATTERIES IN THE INCIDENT CAPIMAGE BATTERY BOX. IT HAS BEEN CONFIRMED THAT THE BATTERY IN INCIDENT SYSTEM HAS BEEN REPLACED TO OBTAIN NORMAL OPERATION. FURTHER ALL DEVICES IN THE FIELD WILL BE UPDATED IN ORDER TO FURTHER REDUCE THE RISK RELATED TO BATTERY OPERATION. THE CAPIMAGE AND SOLOMOBILE IS STILL CONSIDERED TO BE SAFE. THIS WILL CLOSE THE HANDLING OF THIS INCIDENT.

    Description of Event or Problem · 1

    TRIP REPORT (B)(6) 2012 (FROM (B)(4)). THIS REPORT REVIEWS THE TRIP MADE TO (B)(6) TO REPAIR THE CAPIMAGE ON (B)(6) 2012. INITIAL DIAGNOSTIC TESTING CONFIRMED THAT THE UNIT SHUT DOWN WHEN MOVING THE HEAD UP OR DOWN. THE BATTERY BOX WAS REMOVED AND THE VOLTAGE MEASURED WAS 14 VOLTS WHICH NORMALLY SHOULD BE AROUND 48 VOLTS. THE BATTERY BOX WAS REPLACED WITH A NEW ONE SHIPPED FROM (B)(4) AND THE SYSTEM WAS REASSEMBLED. THE UNIT WAS RETURNED TO SERVICE AND THE UNIT WAS CONFIRMED TO BE RUNNING PROPERLY BY THE TECHNOLOGIST (B)(6). ONCE WE GOT BACK TO (B)(4) THE DEFECTIVE BATTERY BOX WAS OPENED AND THE FOUR BATTERIES INSIDE SHOWED HEAVY SIGNS OF OVERHEATING AND BLOATING. THE FOUR BATTERIES WERE ATTACHED TO EACH OTHER BY VIRTUE OF THE BATTERY PLASTIC MELTING AND WELDING TO EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIMAGE GAMMA CAMERA SYSTEM NUCLEAR MEDICINE EQUIPMENT KPS DDD-DIAGNOSTIC A/S NA

    Patients

    Seq Age Sex Outcome Treatment
    1