BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNNIE OB-GYN STRETCHER

    MDR report key: 3020288 · Received March 25, 2013

    Report

    Report Number
    0001831750-2013-02489
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ORIGINALLY REPORTED THAT THE LATCH SPINDLE HAD A CRACKED WELD. UPON COMPLETION OF THE INVESTIGATION IT WAS DISCOVERED THAT THE PUMP PEDAL WELDMENT WAS BROKEN, WHICH WOULD PREVENT THE JACKS FROM BEING PUMPED UP. THE SIDE RAIL AND LATCH DID NOT HAVE ANY DAMAGE AND WERE FUNCTIONING TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE LATCH SPINDLE HAD A CRACKED WELD. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE PUMP PEDAL WELDMENT WAS BROKEN, WHICH WOULD PREVENT THE JACKS FROM BEING PUMPED UP. 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
    122113 GYNNIE OB-GYN STRETCHER STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1