BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI TWIN

    MDR report key: 3140162 · Received May 24, 2013

    Report

    Report Number
    9611530-2013-00052
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) BY THE MANUFACTURER ARJO HOSPITAL EQUIPMENT (B)(4) ON BEHALF OF THE IMPORTER (B)(4). THE DEVICE WAS INSPECTED ON-SITE 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

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232298 MAXI TWIN PASSIVE FLOOR LIFTS FSA ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1