BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPERA

    MDR report key: 2351631 · Received November 22, 2011

    Report

    Report Number
    9681684-2011-00083
    Event Type
    Injury
    Date Received
    November 22, 2011
    Date of Event
    October 21, 2011
    Report Date
    October 24, 2011
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) BY ARJOHUNTLEIGH ((B)(4)) ON BEHALF OF THE MFR BHM MEDICAL, INC. ((B)(4)). PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MFG AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE (B)(4). GOING FORWARD, COMPLAINT RELATED TO THIS PRODUCT ARE TO BE HANDLED BY BHM MEDICAL INC. AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER (B)(4). UPON AN ON-SITE INSPECTION AND TEST PERFORMED BY AN ARJOHUNTLEIGH REPRESENTATIVE ((B)(4)), ALL FUNCTIONS WERE FOUND TO BE WORKING PROPERLY. IT IS NOT POSSIBLE TO REPRODUCE THE INCIDENT ON-SITE. ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    WHILE THE CAREGIVERS WERE RAISING THE RESIDENT FROM HER WHEELCHAIR WITH AN OPERA FLOOR LIFT, THEY HEARD A LOUD CRACK OR A "SKIP OVER" SOUND. THE ORIGINAL DESCRIPTION REPORTED TO THE MFR BY ITS SALES AND SERVICE UNIT WAS THAT THE SPREADER BAR DROPPED DOWN WITH THE RESIDENT. THE SECOND DESCRIPTION REPORTED WAS THAT THE COMPLETE JIB DROPPED DOWN TO THE FLOOR WITH THE RESIDENT. THE RESIDENT WAS TAKEN TO THE EMERGENCY ROOM AND HOSPITALIZED FOR A SHOULDER JOINT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERA MANUFACTURED FLOOR PASSIVE LIFT FSA ARJO MED AB LTD. KPA0300

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R