BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 2110989 · Received April 29, 2011

    Report

    Report Number
    9681684-2011-00031
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT WERE SUBMITTED UNDER REGISTRATION #(B)(4). AS OF 06/15/2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER. GOING FORWARD, ANY MEDWATCH REPORTS ASSOCIATED WITH THIS PRODUCT WILL BE SUBMITTED UNDER REGISTRATION #(B)(4). FURTHER INFO WILL BE PROVIDED UPON MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    WHILE THE NURSE WAS IN PROCESS OF TRANSFERRING THE PT, AFTER SHE HAD LIFTED THE PT FROM THE WHEELCHAIR, SHE SAW THE PT UN-CLIP THE SLING. THE PT FELL THROUGH THE SLING BACK INTO THE WHEELCHAIR, TIPPING THE WHEELCHAIR BACKWARD AND HITTING HIS HEAD. NO INJURIES WERE REPORTED FOR BOTH THE PT AND NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPO MANUFACTURED FLOOR PASSIVE LIFT FSA ARJO MED AB LTD KPA5010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other