BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 3260999 · Received August 2, 2013

    Report

    Report Number
    0001831750-2013-06913
    Event Type
    Malfunction
    Date Received
    August 2, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS REPORTED IN ERROR BY THE USER FACILITY. THERE IS NO REPORTED PRODUCT MALFUNCTION OR COMPLAINT FOR THIS UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WERE REPORTED TO BE BROKEN. MANUFACTURER'S INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WERE REPORTED TO BE BROKEN. MANUFACTURER'S INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363359 SM204 M-SERIES W/BIG WHEEL STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1