BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 2925643 · Received January 22, 2013

    Report

    Report Number
    0001831750-2013-00278
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREVIOUS MDR INITIAL REPORT DID NOT INCLUDE THE PMA/510(K)#.

    Additional Manufacturer Narrative · 1

    LOAD CELL; ZOOM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE UNIT WOULD ZOOM FORWARD WHEN THE HANDLE TRIGGERS WERE ENGAGED WITHOUT PUSHING ON THE HANDLES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE UNIT WOULD ZOOM FORWARD WHEN THE HANDLE TRIGGERS WERE ENGAGED WITHOUT PUSHING ON THE HANDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29699 SM304 M-SERIES W/ZOOM POWERED, STRETCHER, WHEELED INK STRYKER MEDICAL-KALAMAZOO 1025

    Patients

    Seq Age Sex Outcome Treatment
    1