BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM104 MSERIES W5TH WHL

    MDR report key: 2142815 · Received June 20, 2011

    Report

    Report Number
    1831750-2011-06208
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULT: BUMPER CHANNEL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE FOOT PEDAL IS BROKEN AND THE BUMPER CHANNEL IS NOT SECURED TO THE LITTER FRAME. BOTH THE PEDAL AND BUMPER CHANNEL PRESENT SHARP EXPOSED SURFACES. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM104 MSERIES W5TH WHL HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1005 NA

    Patients

    Seq Age Sex Outcome Treatment
    1