BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM104 MSERIES W5TH WHLOBS3/07

    MDR report key: 2933625 · Received January 29, 2013

    Report

    Report Number
    0001831750-2013-00501
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION IT WAS ALSO DETERMINED THAT THE SIDE RAIL COULD NOT REMAIN LATCHED DUE TO A MISSING LATCH SPINDLE AND MISSING TOP RAIL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE FOOT END COVER IS BROKEN AND THERE ARE SHARP EDGES PRESENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE FOOT END COVER IS BROKEN AND THERE ARE SHARP EDGES PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39475 SM104 MSERIES W5TH WHLOBS3/07 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1005

    Patients

    Seq Age Sex Outcome Treatment
    1