BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAXIMOVE

    MDR report key: 1761050 · Received July 8, 2010

    Report

    Report Number
    9611530-2010-00033
    Event Type
    Other
    Date Received
    July 8, 2010
    Date of Event
    June 26, 2010
    Report Date
    June 26, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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) IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT (B)(4) IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6): TWO NURSES MOVING THE PT BACK TO HIS BED. THE HOIST TIPPED DROPPING THE PT ONTO THE BED WITH NO INJURY. ONE OF THE NURSES HAS A SWOLLEN FOOT AND THE OTHER FINISHED UP ON THE FLOOR WITH THE HOIST ACROSS HER CHEST. BOTH STAFF MEMBERS ARE OFF SICK AS A RESULT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMOVE LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB KRA0130

    Patients

    Seq Age Sex Outcome Treatment
    1