BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAISSANCE 26 STRETCHR 11/00

    MDR report key: 3071466 · Received April 22, 2013

    Report

    Report Number
    0001831750-2013-03643
    Event Type
    Malfunction
    Date Received
    April 22, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOOT END CASTER WHEELS WERE DAMAGED, EXPOSING SHARP EDGES AND RESULTING IN REDUCED BRAKE FORCE; PUMP PEDAL PAD WAS MISSING RESULTING IN SHARP EDGES BEING EXPOSED 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
    172110 RENAISSANCE 26 STRETCHR 11/00 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1