BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCE

    MDR report key: 21993674 · Received May 9, 2025

    Report

    Report Number
    3011895992-2025-00001
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    December 9, 2024
    Report Date
    May 8, 2025
    Manufacturer
    GAS CONTROL EQUIPMENT LTD
    Product Code
    CAW
    UDI-DI
    08592346658110
    PMA / PMN Number
    K162433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NEARLY 2 YEARS OLD WITH ONLY 35HRS RUNTIME. NO SIGNS OF ANY INAPPROPRIATE HANDLING DAMAGE OR CONTAMINATION. ERROR LOG HAS 32X6 (LOW BATTERY) AND 23X4 (CHECKVENTS/LOW PURITY) MESSAGES RECORDED. EXCESSIVE DISCHARGE OF BATTERY ENERGY AT THE +, C AND D TERMINALS OF BATTERY CONNECTOR, WHICH APPEARS CENTERED ON THE BATTERY BOARD, UNDER 5 PIN BATTERY CONNECTOR. HEAT CAUSED EVEN THE LEGS OF THE THREE CONNECTOR CONTACTS TO BE MELTED. XRAY FOUND NO SHORTING ELEMENT IN BATTERY CONNECTOR. BOARD IS BURNED AWAY AND HEAT AND FUMES HAVE CAUSED DAMAGE TO SURROUNDING PLASTICS (MELTED AND OR DISCOLOURED) . BATTERY INDICATES NO RESIDUAL CHARGE. BATTERY BOARD TRACKABILITY RECORD IN IMPROBITY WAS FOUND TO BE WRONG (COPY OF MOTHERBOARD S/N!) BUT, BASED ON DEVICES MANUFACTURED AT SAME TIME, BATTERY BOARD BATCH DETERMINED TO BE (B)(6). SYMPTOMS INDICATE CAUSES ARE POTENTIALLY: 1) BOARD DEFECT (SOLDER /TRACK INSULATION) CAUSING SHORT CIRCUIT BETWEEN + AND EITHER C OR D TERMINAL AT THE BATTERY BOARD LAYERS 2) PHYSICAL DAMAGE TO BATTERY BOARD INHOUSE OR BY USER CAUSING SHORT CIRCUIT. 3) CONDUCTIVE FOREIGN OBJECT ACROSS BATTERY TERMINALS ALLOWING/INITIATING ELECTRICAL RETURN PATH (SHORT CIRCUIT) TO BATTERY ELECTRONICS DAMAGE DEFEATING INTERNAL BATTERY PROTECTION CIRCUITRY FURTHER ALLOWING BATTERY ENERGY TO BE DISSIPATED IN THE CREATED CIRCUIT. NO FURTHER FEEDBACK FROM CUSTOMER OR END USER/PATIENT OTHER THAN NO HARM CAUSED. ASSEMBLY SENT TO BATTERY MANUFACTURER BUT NO FURTHER IDENTIFIED POTENTIAL CAUSES WERE IDENTIFIED BY THEM. SAMPLES OF SAME BATCH OF BATTERY BOARD WERE INSPECTED, BUT NO DEFECT OBSERVED.

    Description of Event or Problem · 0

    FRENCH CUSTOMER (NOT END USER/PATIENT) DESCRIBED 'BATTERY FIRE' WITH PHOTOGRAPHS WHICH WERE NOT DETAILED ENOUGH TO DETERMINE SEVERITY. DEVICE (B)(6) AND BATTERY WAS RETURNED TO CZECH REPAIR SITE WHERE FIRST INSPECTION SUGGESTED CATEGORISE HIGH SEVERITY FOR FURTHER INVESTIGATION. DEVICE AND BATTERY WERE SENT TO LEGAL MANUFACTURER UN UK FOR FURHTHER INVESTIGATION. DEVICE NEARLY 2 YEARS OLD WITH ONLY 35HRS RUNTIME. NO SIGNS OF ANY INAPPROPRIATE HANDLING DAMAGE OR CONTAMINATION. ERROR LOG HAS 32X6 (LOW BATTERY) AND 23X4 (CHECKVENTS/LOW PURITY) MESSAGES RECORDED. EXCESSIVE DISCHARGE OF BATTERY ENERGY AT THE +, C AND D TERMINALS OF BATTERY CONNECTOR, WHICH APPEARS CENTERED ON THE BATTERY BOARD, UNDER 5 PIN BATTERY CONNECTOR. HEAT CAUSED EVEN THE LEGS OF THE THREE CONNECTOR CONTACTS TO BE MELTED. XRAY FOUND NO SHORTING ELEMENT IN BATTERY CONNECTOR. BOARD IS BURNED AWAY AND HEAT AND FUMES HAVE CAUSED DAMAGE TO SURROUNDING PLASTICS (MELTED AND OR DISCOLOURED). BATTERY INDICATES NO RESIDUAL CHARGE. BATTERY BOARD TRACKABILITY RECORD IN IMPROBITY WAS FOUND TO BE WRONG (COPY OF MOTHERBOARD S/N!) BUT, BASED ON DEVICES MANUFACTURED AT SAME TIME, BATTERY BOARD BATCH DETERMINED TO BE (B)(6). FINDINGS AND SEVERITY WITH POTENTIAL TO CAUSE HARM, DEVICE DEEMED REPORTABLE INCIDENT. APPEARS TO BE ISOLATED INCIDENT AS NO SIMILAR CASES IN THE FIELDED POPULATION (TENS OF THOUSANDS) HAVE BEEN RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997644 GCE ZEN-O LITE CAW GAS CONTROL EQUIPMENT LTD RS-00600 08592346658110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown