BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE (AHE)

    MDR report key: 1761035 · Received July 8, 2010

    Report

    Report Number
    9611530-2010-00034
    Event Type
    Malfunction
    Date Received
    July 8, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 18, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 AB IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION. TRACK WISE ID.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER 2010-(B)(6): PER THE AHUS SERVICE TECHNICIAN'S INVESTIGATION SUMMARY: "TWO CNAS WAS TRANSFERRING PT FROM THE WHEELCHAIR TO THE BED. ONE AT THE PT END, ONE AT THE DOCKING HANDLE. THEY RAISED HIM OFF OF THE CHAIR AND WHILE TURNING THE LIFT TO THE LEFT, THE FRONT CASTORS WERE NOT PIVOTING TO ALLOW THE LIFT TO EASILY TURN. THE CNA AT THE PT END (B)(6) STATED THAT THE LIFT SEEMED TO TIP BUT DID NOT WITNESS THE CASTORS COMING OFF OF THE FLOOR. THE CNA THAT WAS AT THE DOCKING HANDLE WAS TRYING TO FORCE THE LIFT TO TURN BY HERSELF CAUSING HER TO INJURE HER BACK. THE CNA AT THE DOCKING HANDLE WAS NOT AVAILABLE TO INTERVIEW. FINALLY, THE LIFT WAS TURNED OVER THE BED AND THE PT WAS SAFELY RETURNED TO BED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE (AHE) LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB KMB*

    Patients

    Seq Age Sex Outcome Treatment
    1