BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARJO MECHANICAL LIFT

    MDR report key: 2163495 · Received July 8, 2011

    Report

    Report Number
    MW5021291
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 8, 2011
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6), 2011 AT APPROX 1600 THREE NURSING STAFF IN TO ASSIST PT (CFB) TO COMMODE/BED. PT PLACED IN SLING/SECURED IN PLACE. LIFT POSITIONED PER STANDARDS ACCORDING TO MFR. STAFF POSITIONED EITHER SIDE PT AND AT CONTROLS OF HOYER. WHEN PT RAISED OFF BED AND DURING MOVEMENT TOWARDS BEDSIDE COMMODE, STAFF HEARD TERRIBLE CRACKING SOUND FROM LIFT. OPERATOR OF LIFT MADE STATEMENT "I THINK ITS GOING TO BREAK." OPERATOR MADE QUICK DECISION AND MOVEMENT TO RETURN PT TO BED. AS PT HALF OVER BED/FLOOR ARM OF LIFT SNAPPED CRASHING DOWN ON 2 STAFF ARMS AND PT'S CHEST, HEAD. (STAFF SENT TO EMERGENCY DEPT FOR EVAL). PT LANDED HALF ON BED AND STAFF. MINOR BRUISING TO PT (ASSESSED BY ARNP), MINOR TO STAFF. ARJO MFR NOTIFIED (B)(6) 2011. (B)(6) CLINICAL ENGINEERING NOTIFIED (B)(6) 2011. ARJO IN TO EVALUATE LIFT (B)(6) 2011. LOCATION OF EVENT (B)(6) HOSPITAL ROOM (B)(6) . ON (B)(6) 2011 ARJO REP IN TO REPLACE BROKEN PARTS OF LIFT AND TO SEND BROKEN PARTS BACK TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARJO MECHANICAL LIFT KMB MAXI MOVE SLINGLIFT FNG KMB340SU2FUS 10631

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization