BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY-CAS F/POWER DRIVE F/530.200

    MDR report key: 4801828 · Received May 28, 2015

    Report

    Report Number
    8030965-2015-10660
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Report Date
    July 15, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    MOQ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER¿S PHONE NUMBER: (B)(6). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT THERE WAS AN ISSUE WITH THE POWER DRIVE DEVICE MAKING CONTACT WITH THE BATTERY DEVICE. IT WAS FURTHER REPORTED THAT BECAUSE OF THIS ISSUE THE POWER DRIVE DEVICE DID NOT FUNCTION. IT IS UNKNOWN IF THE MALFUNCTION OCCURRED DURING A SURGICAL PROCEDURE. IT IS UNKNOWN IF THERE WAS ANY PATIENT OR USER INVOLVEMENT. THERE WERE NO REPORTS OF DELAYS, INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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
    346678 BATTERY-CAS F/POWER DRIVE F/530.200 BATTERY, REPLACEMENT, RECHARGEABLE MOQ SYNTHES OBERDORF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 POWER DRIVE| BATTERY DEVICE