BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BATTERY CHARGE II

    MDR report key: 4791833 · Received May 22, 2015

    Report

    Report Number
    1719045-2015-10278
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO VARIOUS WORN ELECTRICAL COMPONENTS FROM NORMAL WEAROUT. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS OBSERVED THAT THE UNIVERSAL BATTERY CHARGER DEVICE WOULD NOT TURN ON AND HAD NO POWER. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. 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
    335778 UNIVERSAL BATTERY CHARGE II BATTERY, REPLACEMENT, RECHARGEABLE HSB SYNTHES MONUMENT 4804

    Patients

    Seq Age Sex Outcome Treatment
    1