BEUDAMED
    FDA Adverse Event Other Summary report: N

    MX-PRO R-3 AMBULANCE COT

    MDR report key: 1033067 · Received April 22, 2008

    Report

    Report Number
    1831750-2008-00075
    Event Type
    Other
    Date Received
    April 22, 2008
    Date of Event
    February 15, 2008
    Report Date
    March 24, 2008
    Manufacturer
    STRYKER CORP. - MEDICAL DIV.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE OPERATIONS MANUAL, THE CHEST RESTRAINT STRAP MUST BE UTILIZED DURING PATIENT TRANSPORT. IN THIS CASE, THE PATIENT WAS NOT PROPERLY RESTRAINED. THE SIDERAILS ARE INTENDED TO INCREASE PATIENT COMFORT AND ARE NOT TO BE USED AS THE PRIMARY PATIENT RESTRAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT WAS ON THE COT AS IT WAS BEING UNLOADED FROM THE AMBULANCE. REPORTEDLY, THE PT LEANED AGAINST THE SIDERAIL. ALLEGEDLY, THE SIDERAIL BROKE AND THE PATIENT FELL. IT WAS REPORTED THAT THE CHEST RESTRAINT STRAPS WERE NOT USED. IT WAS REPORTED THAT THE PATIENT PASSED AWAY, BUT NEITHER THE CAUSE OF DEATH NOR ITS RELATIONSHIP TO THE USE OF THE PRODUCT HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MX-PRO R-3 AMBULANCE COT AMBULANCE COT FPO STRYKER CORP. - MEDICAL DIV. 6082000000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK