BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTOPRONE

    MDR report key: 5996101 · Received October 4, 2016

    Report

    Report Number
    5996101
    Event Type
    Death
    Date Received
    October 4, 2016
    Date of Event
    September 26, 2016
    Report Date
    September 27, 2016
    Manufacturer
    ARJOHUNTLEIGH, INC.
    Product Code
    IKZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PATIENT IN A PRONE THERAPY BED, WAS IN PRONE POSITION AT 15 DEGREES. WITH AIDE OF 2 RN'S PLACED PATIENT TO SUPINE POSITION WITH THE GOAL TO ASSESS THE SKIN/ETT/CVP/ARTERIAL LINES. PATIENT BEING MONITORING CLOSELY FOR SIGNS OF DECOMPENSATION. AFTER 5 MINUTES NOTICED DESATURATIONS, SO QUICKLY WITH THE AIDE OF THE 2 OTHER RN'S PLACED CUSHIONS BACK ONTO PATIENT AND ATTEMPTED TO PLACE BACK INTO PRONE POSITION. THE BED KEPT ALARMING THAT THE CHEST BUCKLES/STRAPS WERE LOOSE AND WOULD NOT LET US COMPLETE PRONE POSITION. ATTEMPTED AT LEAST 3 TIMES TO FIX THE CHEST BUCKLES/STRAPS HOWEVER THE ALARM KEPT RINGING. AT THIS TIME NOTICED THAT PATIENT STARTED TO DESATURATE AND HR DROPPED TO 40'S. A CHEMICAL CODE WAS CALLED. PATIENT BECAME ASYSTOLE/PEA. MEDICATION RESUSCITATION BECAME FUTILE AND WITH FAMILY ATTEMPTS WERE CALLED OFF. PATIENT REPOSITIONING WITH PRONE THERAPY BED. MANUFACTURER RESPONSE FOR PRONE THERAPY BED, ROTOPRONE (PER SITE REPORTER: MANUFACTURER NOTIFIED TO RECEIVE BED FOR INSPECTION. BIOMEDICAL REQUESTING REPORT AND FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648513 ROTOPRONE BED, PATIENT ROTATION, POWERED IKZ ARJOHUNTLEIGH, INC. 209800-R

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death PATIENT IN A PRONE THERAPY BED, WAS IN PRONE POSIT