BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAISSANCE 26 P-WASS 10/04

    MDR report key: 2934064 · Received January 30, 2013

    Report

    Report Number
    0001831750-2013-00520
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 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

    BRAKE CAM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE CUSTOMER ALLEGED THAT THE BRAKE WOULD NOT HOLD. UPON INSPECTION OF THE UNIT BY THE SERVICE TECHNICIAN, IT WAS IDENTIFIED THAT THE BRAKE CAMS ON THE HEAD END AND FOOT END WERE WORN DOWN AND NOT FULLY ENGAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41344 RENAISSANCE 26 P-WASS 10/04 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1