BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI 500

    MDR report key: 3030291 · Received March 28, 2013

    Report

    Report Number
    9681684-2013-00022
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MANUFACTURER ARJOHUNTLEIGH (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

    THE RESIDENT WAS TRANSFERRED FROM BED TO ARMCHAIR, WITHIN BEDROOM. THE SLING WAS APPLIED UNDER RESIDENT. SHE WAS BROUGHT INTO SITTING POSITION AND LIFTED FROM BED. BETWEEN BED AND CHAIR, THE PT WAS FELL OUT OF THE SLING TILL TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127615 MAXI 500 MANUFACTURED FLOOR PASSIVE LIFT FSA ARJOHUNTLEIGH MAGOG INC. KM560104

    Patients

    Seq Age Sex Outcome Treatment
    1