BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 1708122 · Received August 31, 2009

    Report

    Report Number
    1831750-2009-01106
    Event Type
    Malfunction
    Date Received
    August 31, 2009
    Date of Event
    October 10, 2007
    Report Date
    October 10, 2007
    Manufacturer
    STRYKER CORP., MEDICAL DIVISION
    Product Code
    FPO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR REPORTED UPON UNPACKAGING OF THE STRETCHERS, 17 EXHIBITED BRAKE RING DEGRADATION DUE TO THE VIBRATION OF THE SEA TRAVEL. THE DISTRIBUTOR DID NOT REPORT THE SERIAL NUMBERS AFFECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE BRAKES WERE NOT FUNCTIONING TO SPECIFICATION.

    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