BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3802895 · Received May 9, 2014

    Report

    Report Number
    2520274-2014-11362
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 23, 2014
    Manufacturer
    NI
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE FACILITY WAS UNKNOWN. THE DEVICE MANUFACTURE DATE WAS UNKNOWN. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO INTERNAL MOTOR OR ELECTRONIC CONTROL UNIT (ECU) FAILURE DUE TO USAGE WEAR OVER TIME. 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 THAT DURING ROUTINE TESTING, IT WAS DISCOVERED THAT THE SMALL BATTERY DRIVE DEVICE WOULD ¿NOT WORK AT ALL¿. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO PATIENT OR USER INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION ASSOCIATED WITH THIS EVENT. THE EVENT OCCURRED IN APRIL, 2014 HOWEVER THE EXACT DATE 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
    280125 SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE NI 001613

    Patients

    Seq Age Sex Outcome Treatment
    1