BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BATTERY CHARGER II

    MDR report key: 3875105 · Received June 16, 2014

    Report

    Report Number
    2520274-2014-11745
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    MOQ
    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

    THE MANUFACTURING LOCATION WAS UNKNOWN. THE DEVICE MANUFACTURE DATE IS CURRENTLY UNAVAILABLE. 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 USAGE WEAR OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE WAS DOCUMENTED AS JAN 29, 2009 IN THE FOLLOW UP REPORT. THE DEVICE MANUFACTURE DATE HAS BEEN UPDATED AS JULY 30, 2009. 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

    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 JAN 29, 2009. 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 DISCOVERED THAT BAY 3 AND 4 ON THE UNIVERSAL BATTERY CHARGER WOULD NOT CHARGE THE BATTERY DEVICE. IT WAS CLARIFIED THAT THE RED WARNING INDICATOR LIGHTS CAME ON SHORTLY AFTER THE BATTERIES WERE PLUGGED IN. THE EVENT WAS NOT RELATED TO SURGERY. 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
    352076 UNIVERSAL BATTERY CHARGER II BATTERY, REPLACEMENT, RECHARGEABLE MOQ DEPUY SYNTHES POWER TOOLS 9363

    Patients

    Seq Age Sex Outcome Treatment
    1