BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPO

    MDR report key: 2031993 · Received March 17, 2011

    Report

    Report Number
    9681684-2011-00020
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MFG AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE ARJO MED AB LTD (UNDER REGISTRATION (B)(4)). AS OF (B)(6) 2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MFR GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY BHM MEDICAL INC. AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION (B)(4). FURTHER INFO WILL BE PROVIDED UPON MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    TWO CERTIFIED NURSING ASSISTANTS WERE LIFTING A RESIDENT FROM THE CHAIR TO A SHOWER TROLLEY. ONE CERTIFIED NURSING ASSISTANT WAS AT THE DOCKING HANDLE OF THE FLOOR LIFT AND THE OTHER WAS AT THE HEAD OF THE RESIDENT, BEHIND THE CHAIR. WHILE LIFTING OFF OF THE CHAIR, APPROX 3 OR 4 FOOT OFF OF THE FLOOR, THE (B)(6) PULLED THE FLOOR LIFT BACK AND TURNED RIGHT TO GO TO THE TROLLEY WHEN THE LEFT LEG SLING CLIP FELL OFF, CAUSING THE RESIDENT TO SLIDE AND FALL OUT OF THE LEFT SIDE OF THE SLING, HEAD FIRST, HITTING HER HEAD ON THE FRONT EDGE OF THE DOOR. THE (B)(6) AT THE RESIDENT END TRIED TO MOVE QUICKLY TO CATCH THE RESIDENT BEFORE SHE WOULD HIT THE FLOOR. THE (B)(6) HAD TO MANEUVER AROUND THE CHAIR TO GET TO THE RESIDENT AND TRIED TO GUIDE THE RESIDENT EASILY TO THE FLOOR. THE RESIDENT SUSTAINED A CUT TO THE BACK LEFT SIDE THAT REQUIRED 3 STAPLES AND ABRASIONS TO ARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPO LIFT, PATIENT, NON AC POWERED FSA ARJO MED AB LTD. KPB5100-23US

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R