BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM104 M-SERIES W/5TH WHEEL

    MDR report key: 3073406 · Received April 23, 2013

    Report

    Report Number
    0001831750-2013-03679
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR INITIAL REPORT WAS A DUPLICATE OF A PREVIOUSLY ISSUED MDR. PLEASE SEE MDR # 0001831750-2013-03678 FOR INFORMATION REGARDING THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDERAIL WOULD NOT LATCH IN UP POSITION DUE TO BROKEN SPINDLE SPACER. 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 SIDERAIL WOULD NOT LATCH IN UP POSITION DUE TO BROKEN SPINDLE SPACER. 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
    175616 SM104 M-SERIES W/5TH WHEEL STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1