BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARISA

    MDR report key: 1922585 · Received November 19, 2010

    Report

    Report Number
    9611530-2010-00120
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MFG BY ARJO HOSPITAL EQUIPMENT (B)(4) WILL BE REPORTED BY US, THE LEGAL MFR, ARJO HOSPITAL EQUIPMENT (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, ARJOHUNTLEIGH INC., (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE AHUS SERVICE TECH 2010: "(B)(6) WERE MOVING RESIDENT FROM BED TO WHEELCHAIR. RESIDENT WAS IN SLING OVER WHEELCHAIR AT TIME OF INCIDENT. (B)(6) STATED THAT (B)(6) WAS BEHIND RESIDENT'S CHAIR GUIDING RESIDENT DOWN, WHEN THE LIFT "JERKED" DOWN AN INCH OR TWO THEN STOPPED. RESIDENT YELLED IN PAIN AT THE TIME THE LIFT "JERKED". (B)(6) HAD TO PRESS THE HANDSET BUTTON AT LEAST TWO TIMES TO BEGIN THE DOWN CYCLE. RESIDENT WAS AROUND 18 INCHES ABOVE THE WHEELCHAIR AT THIS TIME. WHEN RESIDENT WAS IN HER WHEELCHAIR A NURSE WAS CALLED." ADD'L INFO FROM INTERVIEW 11/01/2010: RESIDENT SUFFERS FROM OSTEOPOROSIS AND HAS HAD FRACTURES IN THE PAST JUST FROM COUGHING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARISA LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB KGA0200

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR