BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 1890667 · Received November 1, 2010

    Report

    Report Number
    1831750-2010-03414
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    STRYKER CORP, MEDICAL DIVISION
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER EVALUATED THE STRETCHER AND ORDERED REPLACEMENT PARTS TO REPAIR THE DEVICE. THE CUSTOMER WAS ASKED TO RETURN THE REPLACED PARTS FOR EVAL. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF THE PARTS ARE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GATCH ASSEMBLY IS LEAKING ONTO THE FLOOR. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM204 M-SERIES W/BIG WHEEL HOSPITAL WHEELED STRETCHER FPO STRYKER CORP, MEDICAL DIVISION 1015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA