BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPO

    MDR report key: 2274697 · Received September 27, 2011

    Report

    Report Number
    9681684-2011-00066
    Event Type
    Injury
    Date Received
    September 27, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE SUBMITTED FOR THE MANUFACTURING SITE ARJO MED. AB LTD ((B)(4)). AS OF 06/15/2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER. 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). ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    WHILE AN ARJOHUNTLEIGH TECHNICIAN WAS AT THE FACILITY FOR AN UNPLANNED REPAIR ON THE FLOOR LIFT, HE WAS INFORMED THAT AN INCIDENT HAD OCCURRED WITH THE DEVICE, WHILE A PT WAS TRANSFERRED TO BED. THE DEVICE TIPPED AND FELL TO THE FLOOR WITH THE PT. THE PT WAS NOT INJURED, BUT SUSTAINED HEAD PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPO MANUFACTURED FLOOR PASSIVE LIFT FSA ARJO MED AB LTD KBP506-23EU

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other