BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI SKY 600 CEILING LIFT

    MDR report key: 2421001 · Received January 13, 2012

    Report

    Report Number
    2421001
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    December 28, 2011
    Report Date
    January 13, 2012
    Manufacturer
    ARJOHUNTLEIGH, INC
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE RECEIVED DOCUMENTS REGARDING A FIELD NOTIFICATION FROM ARJO PERTAINING TO A CEILING MOUNTED PATIENT LIFT. THE STATED PURPOSE OF THE NOTIFICATION IS "(ARJO) RECEIVED A LIMITED NUMBER OF COMPLAINTS OF CEILING LIFTS MOVING WITHOUT THE INTERVENTION OF A CAREGIVER THAT COULD BE LINKED TO ELECTROMAGNETIC INTERFERENCE (EMI). NO INJURIES WERE REPORTED IN CONNECTION WITH THIS ISSUE."ARJO STATES THAT THEY HAVE REVISED THEIR INSTRUCTIONS FOR USE (IFU) MANUAL WITH UPDATED INSTRUCTIONS ON PAGES 48-51.ARJO'S ACTIONS REQUIRED STATES "PLEASE PROMPTLY DISCARD ALL CURRENT MAXI SKY INSTRUCTIONS FOR USE MANUALS AND NOTIFY APPLICABLE PERSONNEL OF THE REVISED INSTRUCTION FOR USE MANUAL."THE MANAGER OF INDUSTRIAL REHABILITATION, STATES "IT APPEARS THE CHANGES PERTAIN PRIMARILY TO PAGES 48-51 FOR ELECTROMAGNETIC COMPATIBILITY. THIS INFORMATION IS HIGHLY TECHNICAL AND INCLUDES MATHEMATICAL CALCULATIONS. THE COMPANY STATES THAT WE MUST RETRAIN OUR STAFF BECAUSE OF THESE CHANGES."THE LANGUAGE IN THIS NOTIFICATION IS AMBIGUOUS. IT DOES NOT STATE WHAT CHANGES WERE MADE TO THE MANUAL, NOR DOES IT SUCCINCTLY ADDRESS WHAT ACTION STEPS THE USERS NEED TO TAKE. A COPY OF THE MANUFACTURER'S NOTICE AND THE INSTRUCTION MANUAL RELATED TO THIS REPORT HAS BEEN PROVIDED TO FDA MEDSUN. ======================MANUFACTURER RESPONSE FOR PATIENT LIFT DEVICE, MAXI SKY 600 CEILING LIFT (PER SITE REPORTER)======================THE DIRECTOR OF BIOMEDICAL ENGINEERING HAS CONTACTED ARJO AND REQUESTED CLARIFICATION OF THEIR NOTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI SKY 600 CEILING LIFT PATIENT LIFT DEVICE FNG ARJOHUNTLEIGH, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *