BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME BIG WHEEL STRETCHER, 30"

    MDR report key: 2923040 · Received December 27, 2012

    Report

    Report Number
    1831750-2012-13365
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT WAS NOT AVAILABLE FOR REVIEW AT FACILITY BY STRYKER TECHNICIAN. MANUFACTURERS INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE PEDAL WAS FLIPPED UPSIDE DOWN ON STRETCHER. UNIT WAS NOT AVAILABLE FOR REVIEW AT FACILITY BY STRYKER TECHNICIAN. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIME BIG WHEEL STRETCHER, 30" HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1115000030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1