BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCE

    MDR report key: 21993760 · Received May 9, 2025

    Report

    Report Number
    3011895992-2025-00002
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    February 18, 2025
    Report Date
    May 9, 2025
    Manufacturer
    GAS CONTROL EQUIPMENT LTD
    Product Code
    CAW
    UDI-DI
    08592346004337
    PMA / PMN Number
    K162433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED WITH NO INFORMATION AND WAS MISSING BATTERIES AND BATTERY COVER. INSPECTION FOUND DEVICE TO STILL POWER UP WITH EXTERNAL POWER APPLICATION SHOWING IT HAD ONLY RUN 17 HRS DESPITE BEING MANUFACTURED IN JULY 2019. DEVICE IS OUTSIDE IT'S SERVICE LIFE (5 YEARS). IT IS UNKNOWN AT THIS POINT IF EVENT OCCURED WITHIN SERVICE LIFE OR NOT. DISASSEMBLY AND FURTHER INSPECTION SHOWED MELTING OF THE REAR COVER AND BOTTOM OF IT'S BATTERY COMPARTMENT INDICATING THAT THE HEAT WAS GENERATED WITHIN THE REAR BATTERY PACK. PARTS OF THE BATTERY LABEL WERE HEAT WELDED TO THE INSIDE OF THE BATTERY COMPARTMENT AND THE REAR BATTERY HAD BEEN LEVERED OUT OF THE COMPARTMENT AS INDICATED BY THE REAR FRAME DEFORMATIONS AROUND THE ENTRANCE APERTURE. BATTERY BOARD, ALTHOUGH COVERED IN METALIC FUME COATING AND MELTED PLASTICS OTHERWISE LOOKED INTACT. DARK LIQUID RUNS FROM THE MELTED AREA SEEN. BATTERIES WERE REQUESTED FROM RETURNING CUSTOMER (OXYGEN SALUD S.A. (SPAIN)), BUT WE ARE INFORMED BATTERIES WERE SCRAPPED IN SPAIN (NO PHYSICAL EVIDENCE OR PHOTOS AVAILABLE). WITHOUT THE BATTERIES NO FURTHER EVALUATION / ROOT CAUSE INVESTIGATION COULD BE MADE. IT IS SUSPECTED THAT THE BATTERIES MAY WELL HAVE DETERIORATED DUE TO LACK OF USE OVER YEARS AND/OR WHEN ATTEMPTED TO BE USED RESPONDED ADVERSELY. NO ROOT CAUSE COULD BE IDENTIFIED DUE TO LACK OF EVIDENCE. MANUFACTURER IS NOT AWARE OF ANY SIMILAR FAILURES OF THIS MEDICAL DEVICE.

    Description of Event or Problem · 0

    DEVICE WAS RETURNED TO REPAIR CENTER WITH NO INFORMATION AND WAS MISSING BATTERIES AND BATTERY COVER. MELTED HOLE IN THE REAR OF THE DEVICE WAS OBSERVED. DISASSEMBLY AND FURTHER INSPECTION SHOWED ADDITIONAL MELTING OF THE BOTTOM OF IT'S BATTERY COMPARTMENT INDICATING THAT EXCESSIVE HEAT WAS GENERATED WITHIN THE REAR BATTERY PACK. EVIDENCE OF SMOKE/FUMES HAVING EXITED THE DEVICE WAS ALSO OBSERVED. ALTHOUGH NO REPORT OF HARM CAUSED TO USER/PATIENT , HIGH TEMPERATURE EVENT IS CONSIDERED TO HAVE POTENTIAL TO CAUSE HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997667 GCE ZEN-O CAW GAS CONTROL EQUIPMENT LTD RS-00500 08592346004337

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown