BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM104 MSERIES W5TH WHLOBS3/07

    MDR report key: 3073182 · Received April 23, 2013

    Report

    Report Number
    0001831750-2013-03669
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE OF MFR REPORT # 0001831750-2013-03665. THE SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1005000000 REPORTED FOR THIS COMPLAINT WERE ACCIDENTALLY SUBMITTED INTO THE COMPLAINT HANDLING SYSTEM TWICE FOR THE EXACT SAME COMPLAINT INSTANCE. PLEASE REFER TO MFR REPORT # 0001831750-2013-03665 FOR FULL REPORTING OF SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1005000000 FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL COULD NOT REMAIN LATCHED DUE TO BROKEN SPINDLE BEARING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    THIS IS A DUPLICATE OF MFR REPORT # 0001831750-2013-03665. THE SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1005000000 REPORTED FOR THIS COMPLAINT WERE ACCIDENTALLY SUBMITTED INTO THE COMPLAINT HANDLING SYSTEM TWICE FOR THE EXACT SAME COMPLAINT INSTANCE. PLEASE REFER TO MFR REPORT # 0001831750-2013-03665 FOR FULL REPORTING OF SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1005000000 FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174888 SM104 MSERIES W5TH WHLOBS3/07 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1