BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARISA

    MDR report key: 2742700 · Received September 11, 2012

    Report

    Report Number
    9611530-2012-00160
    Event Type
    Malfunction
    Date Received
    September 11, 2012
    Date of Event
    August 16, 2012
    Report Date
    August 16, 2012
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC ON BEHALF OF THE MFR ARJO MED (B)(4). PLEASE NOTE THAT WHILE THIS PRODUCT IS NO LONGER MFG, PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE ARJO MED (B)(4). AS OF (B)(4) 2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MFR. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJO HOSPITAL EQUIPMENT (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY CUSTOMER (B)(6) 2012: MARISA DEVICE WAS BEING USED WHEN THE LIFT ARM EITHER CAME LOOSE OR DETACHED FULLY, CAUSING THE RESIDENT TO FALL FROM A HEIGHT OF APPROXIMATELY 6 INCHES (NO INJURY WAS REPORTED). ARJOHUNTLEIGH SERVICE TECH WAS PAGED OUT. "DIRECTOR OF NURSING AND DIRECTOR OF FACILITY SERVICE STATED THAT WHILE RAISING THE RESIDENT ON THE LIFT IN ORDER TO TRANSFER THE RESIDENT THE LIFTING ARM/SPREADER BAR ASSEMBLY DETACHED FROM CARRIAGE ALLOWING THE RESIDENT TO FALL. THE RESIDENT WAS NOT INJURED AND DOES NOT NEED TO BE HOSPITALIZED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARISA PASSIVE FLOOR LIFTS FSA ARJO MED AB LTD KGB2100

    Patients

    Seq Age Sex Outcome Treatment
    1