BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER-PRO TL COT

    MDR report key: 2091038 · Received May 11, 2011

    Report

    Report Number
    1831750-2011-04513
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    INK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BOLT HOLES IN SUB FRAME. IT WAS DETERMINED THERE IS A POTENTIAL RISK TO SAFETY IF THE COT COMES OUT OF THE FASTENER SYSTEM WHEN LOADING BECAUSE THIS COULD POTENTIALLY RESULT IN INJURY TO THE PT AND/OR CAREGIVER. IT WAS REPORTED THAT ONE OF THE COTS WORKED ITSELF LOOSE FROM A FASTENER OVER REPEATED USE, HOWEVER THE CUSTOMER HAS 11 COTS AND IT CANNOT BE DETERMINED WHICH COT WAS INVOLVED IN THE REPORTED INCIDENT OF COMING LOOSE FROM THE FASTENER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE COT CAME FREE FROM THE FASTENING SYSTEM. THERE WAS PT INVOLVEMENT, HOWEVER NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER-PRO TL COT STRETCHER, WHEELED INK STRYKER MEDICAL 6550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1