BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMOVE (II)

    MDR report key: 1812383 · Received August 20, 2010

    Report

    Report Number
    9611530-2010-00056
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT (B)(4), THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER ON THE 2010-(B)(6): (YYYY/MM/DD). THE RESIDENT WAS POSITIONED IN HER WHEEL CHAIR, INSIDE THE SHOWER ROOM. TWO AIDS HAD RESIDENT POSITIONED IN SLING AND HOOKED TO LIFT. WHEN LIFTING THE LOOP/STRAP THAT ATTACHES THE CLIP TO THE SLING BROKE. THE RESIDENT THEN FELL BACK DOWN INTO HER WHEEL CHAIR. NO INJURIES OCCURRED WHEN SLING FAILED. SLING PART NUMBER MAA4000-XL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMOVE (II) LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB KMBB40LU2FUS

    Patients

    Seq Age Sex Outcome Treatment
    1