BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARISA

    MDR report key: 1971725 · Received December 29, 2010

    Report

    Report Number
    9611530-2010-00128
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    July 12, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER 2010-(B)(6): PER THE FACILITY'S MEDWATCH FORM - "2 CNA'S WERE TRANSFERRING RESIDENT FROM BED TO WHEELCHAIR WITH A MARISA LIFT. THE SLING WAS PLACED UNDERNEATH AND ATTACHED VIA 4 CLIPS TO LIFT. CNA'S BOTH STATED THEY HEARD SLING "CLICK." WHILE RESIDENT WAS IN THE AIR, THE LEFT LEG BUCKLE UNHOOKED FROM THE LIFT CAUSING THE RESIDENT TO SLIP OUT AND HIT HEAD ON FLOOR. RESIDENT WAS TRANSFERRED TO ER AND RETURNED LATER [THE] SAME DAY WITH A DIAGNOSIS OF ABRASION AND CONTUSION." NOTE - AHUS RECEIVED THE FACILITY MEDWATCH REPORT ON (B)(6) 2010 (IT IS UNK IF THEY ALSO SENT IT IN TO THE FDA). AN AHUS SERVICE TECH WENT ON-SITE FOR THE INVESTIGATION ON 12/23/2010. (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 OTHER

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR