BEUDAMED
    FDA Adverse Event Death Summary report: N

    POSITIONPRO WITH PENDANT

    MDR report key: 3995017 · Received August 8, 2014

    Report

    Report Number
    0001831750-2014-03201
    Event Type
    Death
    Date Received
    August 8, 2014
    Date of Event
    May 13, 2014
    Report Date
    July 16, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ON THE MATTRESS CODED AND REQUIRED CPR. WHILE PERFORMING CPR, THE MATTRESS¿ SELF-ASSIST TURN FUNCTION WAS ACTIVATING ON ITS OWN DUE TO A PENDANT MALFUNCTION. CONVERSATION WITH HEALTHCARE PROFESSIONALS AT THE USER FACILITY CONFIRMED THAT THE PATIENT CODED PRIOR TO THE MALFUNCTION OCCURRING AND WAS NOT RELATED TO THE ALLEGED MALFUNCTION; THAT THE MATTRESS MALFUNCTION DID NOT AFFECT THEIR ABILITY TO PERFORM CPR; AND FURTHER, IT WAS CONFIRMED BY THE USER FACILITY THAT THE CPR HANDLES WERE NOT PULLED OUT AS IS INSTRUCTED PRIOR TO PERFORMING CPR. HOWEVER, THE PATIENT COULD NOT BE RESUSCITATED AND SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470087 POSITIONPRO WITH PENDANT MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1