BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPERA

    MDR report key: 2444290 · Received February 8, 2012

    Report

    Report Number
    9681684-2012-00010
    Event Type
    Death
    Date Received
    February 8, 2012
    Date of Event
    December 17, 2011
    Report Date
    January 6, 2012
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (B)(4)) ON BEHALF OF THE MANUFACTURER ARJOHUNTLEIGH (B)(4). PLEASE NOTE THAT WHILE THIS PRODUCT IS NO LONGER MANUFACTURED, PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO (B)(4). AS OF 06/15/2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY BHM MEDICAL, INC. AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER (B)(4). THE EVALUATION OF THE DEVICE TO DATE HAS BEEN CARRIED OUT BY A REPRESENTATIVE OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE FLOOR LIFT AND SLING WERE USED TO PROCEED TO THE TRANSFER OF A RESIDENT FROM BED. THE STAFF VISUALLY INSPECTED ALL SLING CLIPS, LIFTED THE RESIDENT AND STARTED TO PULL THE LIFT AWAY FROM THE BED. THE STAFF THEN BROUGHT THE RESIDENT IN A SITTING POSITION IN THE SLING USING THE DYNAMIC POSITIONING SYSTEM'S LEVER. AT THIS MOMENT, SHE NOTICED THAT ONE OF THE CLIP HAD COME OFF AND RESIDENT STARTED TO FALL. THE STAFF TRIED TO CATCH HIM BUT WAS UNABLE. RESIDENT LANDED ON FLOOR AND STRUCK HIS HEAD. THE PATIENT SUFFERED BRUISING ON THE FACE, BACK OF THE HEAD AND ON ONE SHOULDER; EXPIRED 6 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERA MANUFACTURED FLOOR PASSIVE LIFT FSA ARJO MED AB LTD. KPB32250-22US

    Patients

    Seq Age Sex Outcome Treatment
    1 105 YR Death