BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOANER CORDLESS DRIVER 3

    MDR report key: 2851172 · Received October 29, 2012

    Report

    Report Number
    1811755-2012-03913
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE LOANER CORDLESS DRIVER WAS SENT FOR SVC AND IT RAN IN SAFE MODE DURING PERFORMANCE TESTING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOANER CORDLESS DRIVER 3 HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK