BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATT F/NOS. 532.101+532.110

    MDR report key: 3232966 · Received July 18, 2013

    Report

    Report Number
    8030965-2013-04386
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE AS RECEIVED CONDITION WAS THE HOUSING OF THE BATTERY IS PARTLY MOLTED. THE COMPLAINED BATTERY WAS FORWARDED TO THE SERVICE DEPARTMENT FOR INVESTIGATION. WE ARE NOW IN THE RECEIPT OF THEIR FINDINGS. THE INVESTIGATION OF THE COMPLAINT ARTICLE HAD SHOWN THAT THE HOUSING OF THE BATTERY IS PARTLY MOLTED. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO TH IS OCCURRENCE. WE SUPPOSE THAT THE BATTERY WAS TOGETHER WITH THE COLIBRI INTO THE AUTOCLAVE. THE BATTERY SHOWS SAME CORRESPONDING TRACES. IT IS NOT POSSIBLE THAT THIS DAMAGE OCCUR DURING USE, THE COLIBRI AUTOMATICALLY SHUT OFF AT 85°C. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE BATTERY BECAME WARM DURING SURGERY ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334074 BATT F/NOS. 532.101+532.110 HWE SYNTHES GMBH 120227

    Patients

    Seq Age Sex Outcome Treatment
    1