BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAISSANCE 29 P-WASHOBS10/04

    MDR report key: 3170086 · Received June 14, 2013

    Report

    Report Number
    0001831750-2013-05407
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    April 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE ZOOM DISENGAGES DURING USE DUE TO MALFUNCTIONED HANDLE CABLES. 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
    271842 RENAISSANCE 29 P-WASHOBS10/04 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1