BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAISSANCE 29 P-WASHOBS10/04

    MDR report key: 3212576 · Received July 9, 2013

    Report

    Report Number
    0001831750-2013-06168
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 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 WOULD MOVE UNINTENTIONALLY DUE TO A MALFUNCTIONED LOAD CELL. 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
    312806 RENAISSANCE 29 P-WASHOBS10/04 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1