BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER MODULE F/TRS

    MDR report key: 6181305 · Received December 16, 2016

    Report

    Report Number
    8030965-2016-15970
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 2, 2016
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). REPORTER¿S PHONE NUMBER: (B)(6). THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE. A FUNCTIONAL ASSESSMENT WAS PERFORMED AND THE DEVICE WORKED AS EXPECTED AND NO FAILURES WERE IDENTIFIED. THE REPORTED CONDITION WAS NOT 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 FROM (B)(6) THAT THE ENGINE/MOTOR OF THE POWER MODULE DEVICE WAS NOT FUNCTIONING PROPERLY AND THE BATTERY DEVICE BECAME VERY HOT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT. 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
    831148 POWER MODULE F/TRS BATTERY, REPLACEMENT, RECHARGEABLE MOQ SYNTHES OBERDORF N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 BATTERY DEVICE