BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY CASING F/BPL

    MDR report key: 3922838 · Received July 9, 2014

    Report

    Report Number
    2520274-2014-12436
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    MOQ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER LOCATION WAS DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT. THE LOCATION HAS BEEN UPDATED TO (B)(4). CONTACT OFFICE NAME/ADDRESS HAS BEEN UPDATED ACCORDINGLY TO REFLECT THE CORRECT MANUFACTURING FACILITY. DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE WAS DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT. THE DEVICE MANUFACTURE DATE HAS BEEN UPDATED AS AUG 3, 2010. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION WAS UNKNOWN. DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE IS CURRENTLY UNAVAILABLE. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS NOT DUPLICATED OR CONFIRMED. THEREFORE, AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO SURGERY, IT WAS OBSERVED THAT THE BATTERY CASING DEVICE WAS HEATING UP AND STARTED SMOKING. THE REPORTER STATED LIKE IT SMELLED LIKE AN ELECTRIC FIRE. THERE WERE NO DELAYS TO THE PLANNED SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400006 BATTERY CASING F/BPL BATTERY, REPLACEMENT, RECHARGABLE MOQ SYNTHES OBERDORF 007153

    Patients

    Seq Age Sex Outcome Treatment
    1