BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER LOAD

    MDR report key: 3232401 · Received July 18, 2013

    Report

    Report Number
    0001831750-2013-06430
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    January 17, 2013
    Report Date
    June 20, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWER-LOAD LIFTING ISSUE WAS NOT DETERMINED AS IT WAS REPORTED THAT THE ISSUE WAS NOT DUPLICATED DURING THE TIME OF EVALUATION. HOWEVER, BASED ON PREVIOUS SIMILAR INVESTIGATIONS A POTENTIAL CAUSE FOR THE LIFTING ISSUE MIGHT BE ATTRIBUTED TO THE COT NOT BEING LOADED PROPERLY INTO THE POWER-LOAD TROLLEY. IF THE HEAD SECTION IS NOT PROPERLY EXTENDED AND LOCKED, OR IF THE COT IS LOADED ON AN ANGLE, AS THE COT IS BEING RAISED, THE TROLLEY ARMS MAY SLIDE OFF OF THE COT LEGS AND CONTACT THE APPROPRIATE POSITION ON THE BASE OF THE COT. THIS SLIDING OF THE TROLLEY ARMS IS THE DROP EVENT DESCRIBED BY THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER LOAD DROPPED DOWN TO THE LOWEST LEVEL FROM THE HIGHEST LEVEL WITH A PATIENT ON THE COT. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER LOAD DROPPED DOWN TO THE LOWEST LEVEL FROM THE HIGHEST LEVEL WITH A PATIENT ON THE COT. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334431 POWER LOAD STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1