BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI MOVE

    MDR report key: 2163427 · Received July 4, 2011

    Report

    Report Number
    9611530-2011-00050
    Event Type
    Injury
    Date Received
    July 4, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH ON BEHALF OF THE MANUFACTURER ARJO HOSPITAL EQUIPMENT AB (REGISTRATION (B)(4)) ON BEHALF OF THE MFR ARJO HOSPITAL EQUIPMENT AB (REGISTRATION (B)(4)). THE FACILITY INFORMED THE ARJOHUNTLEIGH SERVICE TECH DURING THE ON-SITE INVESTIGATION THAT THEY HAD NEVER BEEN IN-SERVICED ON THE USE OF THE TOILET SLINGS. ARJOHUNTLEIGH SALES HAS BEEN NOTIFIED IN ORDER TO SET UP IN-SERVICING FOR RELEVANT PERSONNEL. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    STAFF MEMBERS PLACED THE RESIDENT IN AN EXTRA LARGE TOILET SLING TO TRANSFER HER FROM A CHAIR TO HER BED. WHEN THEY LIFTED HER UP OFF THE CHAIR, HER REAR END SLID THROUGH THE SLING. SHE HIT THE GROUND WITH HER BUTTOCKS FIRST THEN FELL BACK, HITTING HER HEAD ON THE GROUND. THE RESIDENT SUFFERED A LACERATION TO HER HEAD, REQUIRING 8 STAPLES TO CLOSE THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE PASSIVE FLOOR LIFT FSA ARJO HOSPITAL EQUIPMENT AB KMBB4ELU2FUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R