BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMOVE

    MDR report key: 1812361 · Received August 20, 2010

    Report

    Report Number
    9611530-2010-00057
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION. EVALUATION: INFORMATION OBTAINED VIA TELEPHONE DUE TO LOGISTICS; ALSO, CUSTOMER ADMITS USER ERROR IS NOT USING SLING CORRECTLY.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER ON 07/08/2010. A SUPPOSITORY HAD BEEN GIVEN AND RESIDENT INDICATED SHE NEEDED TO VOID. SHE HAS MOVED HERSELF TO THE END OF THE BED AND STAFF APPLIED TOILET SLING, TRANSFERRED HER TO COMMODE BESIDE BED, SHE REMAINED CONNECTED TO SLING WHILE ON COMMODE, STAFF CLEANED HER WHEN FINISHED. STAFF ON BOTH SIDES OF RESIDENT IN FRONT OF HER. RESIDENT WAS HANGING ON TO HANGER BAR, WHEN SHE LIFTED BOTH ARMS IN THE AIR ABOVE SHOULDER AND FELL THROUGH SLING SO FAST STAFF COULD NOT REACT QUICKLY ENOUGH. SHE FELL THROUGH SLING WITH LEGS IN THE AIR. COMMODE WAS FACING HEAD OF BED, SPACE WAS TIGHT, RESIDENT WAS FACING THE LIFT. HEAD AND ... (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMOVE LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB KRA0300

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR