BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 2993684 · Received March 7, 2013

    Report

    Report Number
    8030965-2013-00780
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED OR DUPLICATED. THE UNIT WAS TESTED AND PASSED ALL OPERATIONAL SPECIFICATIONS AND NO PROBLEMS WERE NOTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE IS A VETERINARY PRODUCT. DEVICE IS SIMILAR TO A DEVICE MARKETED FOR HUMAN USE. OPERATOR OF DEVICE IS HEALTH PROFESSIONAL, BUT IN VETERINARY FIELD.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS OF THIS HOUSING WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE SERIAL NUMBER (B)(4) BELONGS TO THE PART 50140440, WHICH IS THE HOUSING OF THE ARTICLE 532.010. PLACEHOLDER.

    Description of Event or Problem · 1

    THIS REPORT IS #1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT ON (B)(6) 2013, A SMALL BATTERY DRIVE WOULD PERIODICALLY START AND STOP. DEVICE WAS NOT USED IN SURGERY. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED. THIS DEVICE WAS USED AT A VETERINARY CLINIC. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97178 SMALL BATTERY DRIVE HWE SYNTHES GMBH 004707

    Patients

    Seq Age Sex Outcome Treatment
    1