BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASTVAC W/8 FOOT HOSE AND MOBILE STAND

    MDR report key: 2891029 · Received November 14, 2012

    Report

    Report Number
    1811755-2012-04060
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 15, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    LGH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED FAILURE OF SPARKING COULD NOT BE DUPLICATED DURING THE DEVICE EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY, THE MOTOR OF THE DEVICE WAS SPARKING. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTVAC W/8 FOOT HOSE AND MOBILE STAND LGH STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK