BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BATTERY CHARGER - 4 BAYS

    MDR report key: 3895014 · Received June 25, 2014

    Report

    Report Number
    8030965-2014-10308
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    April 1, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    MOQ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND IT WAS OBSERVED THAT THE BATTERY CONTACTS WERE DAMAGED. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING STERILE PROCESSING, IT WAS DISCOVERED THAT THE UNIVERSAL BATTERY CHARGER DEVICE WAS NOT CHARGING BATTERIES. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED ON (B)(6) 2014. 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
    370850 UNIVERSAL BATTERY CHARGER - 4 BAYS BATTERY, REPLACEMENT, RECHARGEABLE MOQ SYNTHES OBERDORF 44667

    Patients

    Seq Age Sex Outcome Treatment
    1