BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPERA

    MDR report key: 4383579 · Received January 5, 2015

    Report

    Report Number
    3007420694-2015-00004
    Event Type
    Death
    Date Received
    January 5, 2015
    Date of Event
    December 17, 2014
    Report Date
    December 19, 2014
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR MANUFACTURING SITE ARJO MED. AB LTD (UNDER REGISTRATION #9617021). AS OF 06/15/2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER AND UNTIL 2014 COMPLAINTS RELATED TO THESE PRODUCTS WERE HANDLED BY ARJO HOSPITAL EQUIPMENT AB AND ANY MEDWATCH REPORTS WERE SUBMITTED UNDER REGISTRATION #9681684 (B)(4)(ARJOHUNTLEIGH (B)(4)/ 9681684). FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH (B)(4)'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694 UNDER EXEMPTION (B)(4) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH (B)(4) (REGISTRATION #1419652). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT THE PT WENT TO THE TOILET BY HIMSELF AND WAS THEN FOUND ON THE FLOOR. THE HOIST (OPERA LIFT) AND THE DISPOSABLE "FLITE" SLING WAS USED TO LIFT THE PT OFF THE FLOOR. DURING THE LIFTING PROCESS THE DISPOSABLE "FLITE" SLING BEGAN TO RIP/TEAR. WHEN THE CAREERS REALIZED THE SLING WAS RIPPING THE PT WAS LOWERED AND ANOTHER NEW SLING WAS THEN USED SUCCESSFULLY TO RAISE THE PT. NO INJURIES WERE CAUSED BY THE HOIST OR THE SLING BUT THE PT TREATMENT WAS DELAYED. IT WAS INDICATED THAT THE PT HAD BROKEN NECK AND FEMUR IN A FALL PRIOR TO USING HOIST/SLING. IT WAS REPORTED THAT THIS PT HAD MULTIPLE COMORBIDITIES DUE TO METASTATIC CANCER. IT WAS INDICATED THAT THE PT PASSED AWAY ONE DAY AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209 OPERA FSA ARJO MED AB LTD KPA0300

    Patients

    Seq Age Sex Outcome Treatment
    1 Death