BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIRANTI/RHAPSODY

    MDR report key: 1847912 · Received September 23, 2010

    Report

    Report Number
    9611530-2010-00065
    Event Type
    Death
    Date Received
    September 23, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION #(B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, ARJO INC, (B)(4).

    Description of Event or Problem · 1

    AS STATED BY THE (B)(4) SERVICE TECH (B)(6)2010: "NURSE FILLED TUB, LOWERED RESIDENT INTO WATER, WATER CAME UP TO HER ARMPIT AREA, GAVE RESIDENT BATH. NURSE THEN LEFT THE ROOM WHILE RESIDENT WAS STILL LOWERED IN THE WATER. NURSE CAME BACK AFTER AN UNK AMOUNT OF TIME THAT IS WHEN THE NURSE FOUND THE RESIDENT NOT BREATHING. THE NURSE ALSO STATED THAT THE AREA WHERE THE WATER WAS AT, ON THE RESIDENT, WAS DIFFERENT, NOW UP AROUND THE CHIN AREA." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRANTI/RHAPSODY LIFT, PATIENT, NON-AC-POWERED/ASSISTED, BATH FSA ARJO HOSPITAL EQUIPMENT AB CEB8003-01/AR33211-US

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR