BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTOPRONE

    MDR report key: 3667359 · Received February 7, 2014

    Report

    Report Number
    3010048749-2014-00004
    Event Type
    Death
    Date Received
    February 7, 2014
    Date of Event
    January 28, 2014
    Report Date
    January 28, 2014
    Manufacturer
    ARJOHUNTLEIGH INC.
    Product Code
    IKZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED BY THE MFR ARJOHUNTLEIGH INC. PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FROM THE MFG SITE (B)(4). AS OF (B)(4) 2012, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH, INC. ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR INVESTIGATION.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO ARJOHUNTLEIGH BY THE NURSE: ON (B)(6) 2014, THE BED WAS ALARMING HATCH OR BUCKLE OPEN. THE NURSE TIGHTENED ALL BUCKLES AND HATCHES THEN RE-BOOTED THE BED. THE BED WOULD NOT MECHANICALLY PRONE AFTER FOLLOWING INSTRUCTIONS ON THE COMPUTERIZED SCREEN. ARJOHUNTLEIGH CUSTOMER TECHNICAL SERVICES WAS CALLED AND PER THE ARJOHUNTLEIGH TECHNICAL SERVICE REP'S INSTRUCTIONS THE PT WAS PLACED IN THE SUPINE POSITION, THE BED WAS UNPLUGGED, THE BATTERY BUTTON WAS PUSHED, AND THEN THE BED WAS PLUGGED BACK IN. WHILE WAITING FOR THE BED TO RE-BOOT, THE PT'S OXYGEN SATURATION DECREASED EXPONENTIALLY. ONCE THE BED WAS RE-BOOTED THE NURSE ATTEMPTED TO ROTATE THE PT TO THE PRONE POSITION. THE BED ROTATED UP TO 62 DEGREES ON THE LEFT SIDE, AND STOPPED WITH ERROR MESSAGES DISPLAYING AGAIN. AT THIS TIME, THE PT LOST A PULSE. THE CPR BUTTON AND EMERGENCY HANDLE WERE RELEASED, THE PT WAS ROTATED TO THE SUPINE POSITION AND CPR STARTED. CPR WAS UNSUCCESSFUL AND SUBSEQUENTLY THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81341 ROTOPRONE IKZ ARJOHUNTLEIGH INC. 209500

    Patients

    Seq Age Sex Outcome Treatment
    1 Death