BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNNIE OB-GYN STRETCHER

    MDR report key: 2191387 · Received July 28, 2011

    Report

    Report Number
    1831750-2011-07798
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: FOWLER, FOWLER TUBE, OUTER HOUSING ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SVC REPORT THAT THE FOWLER WOULD NOT LOCK IN PLACE AND COULD NOT BE LOWERED. THE CUSTOMER COULD NOT DETERMINE WHETHER THERE WAS PT INVOLVEMENT OR ADVERSE CONSEQUENCES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNNIE OB-GYN STRETCHER HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1061 NA

    Patients

    Seq Age Sex Outcome Treatment
    1