BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCE

    MDR report key: 22606964 · Received July 25, 2025

    Report

    Report Number
    3011895992-2025-00003
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 25, 2025
    Manufacturer
    GAS CONTROL EQUIPMNET LTD
    Product Code
    CAW
    UDI-DI
    08592346658110
    PMA / PMN Number
    K162433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING SERVICING THE DEVICE'S INTERNAL INSPECTION FOUND BATTERY BOARD OVERHEATING AND BURNED SURFACES WITH EVIDENCE OF SOME SMOKE GENERATION. DEVICE ZL306340 MANUFACTURED 07/2/2023 HOWEVER ON RECEIPT AT SERVICE CENTER HAD ONLY 8 HRS RUNTIME WHICH WOULD HAVE BEEN MOSTLY FACTORY RUNNING PRIOR TO SALE. EFFECTIVELY UNUSED DEVICE AFTER NEARLY 2 1/2 YEARS. BATTERY POWER DISSIPATED AT THE BATTERY CABLE CONNECTION TO THE BATTERY BOARD DUE TO SOME FORM OF SHORT CIRCUIT. 320 OHM REMAINS BETWEEN + AND - BATTERY CONNECTION TERMINALS EVEN AFTER BURNING OF THE BOARD. POST BASE REPLACEMENT , DEVICE RAN 1HR 35MINS ON FULL BATTERY, (IFU 1HR 30 MINS GUIDE) INDICATING NO OTHER ISSUE WITH THE DEVICE. ENVIRONMENT CAUSED FURRING OF SOLDER JOINTS OR FOREIGN OBJECT SHORT CIRCUIT OF BATTERY TERMINALS OR DEFECT IN BATTERY BOARD ARE POSSIBLE CAUSES BUT NOT WHOLLY IDENTIFIABLE FROM THE REMAINING MATERIAL. ONLY ONE SIMILAR INCIDENT EVER PREVIOUSLY OBSERVED OF SIMILAR AGE AND LACK OF ACTUAL USE.

    Description of Event or Problem · 0

    DEVICE RETURNED FOR SERVICE WITH NO REFERENCE TO BEING A DEVICE OF SPECIAL INTEREST OR ANY SIGNIFICANT/ADVERSE EVENT OCCURRING WITH IT, BY CUSTOMER - (B)(6). DURING SERVICING THE DEVICE'S INTERNAL INSPECTION FOUND BATTERY BOARD OVERHEATING AND BURNED SURFACES WITH EVIDENCE OF SOME SMOKE GENERATION. BELIEVE INCIDENT OCCURRED WHILST DEVICE WAS IN (B)(6). POTENTIAL TO HAVE CAUSE HARM DETERMINED BY REPAIR FACILITY IN CZECH REPUBLIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2383659 GCE ZEN-O LITE CAW GAS CONTROL EQUIPMNET LTD RS-00600 08592346658110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown