BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 2607754 · Received May 23, 2012

    Report

    Report Number
    9681684-2012-00040
    Event Type
    Malfunction
    Date Received
    May 23, 2012
    Date of Event
    May 3, 2012
    Report Date
    May 3, 2012
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY (B)(4) ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4) INC., (B)(4). MFR COMPLAINT NUMBER: (B)(4). PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE ARJO MED (B)(4) LTD (UNDER REGISTRATION #(B)(4). AS OF (B)(4) 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 ARJOHUNTLEIGH (B)(4) AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION (B)(4). ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    A RESIDENT WAS BEING LIFTED INTO THE TUBE WITH A FLOOR LIFT. WHILE THE FLOOR LIFT WAS AT ITS HIGHEST POINT, THE CAREGIVER MANUALLY LIFTED THE RESIDENT OVER TUB LIP. THEN, THE DEVICE'S FRONT CASTER PRESSED AGAINST THE TUB'S FRONT LEG AND THE FLOOR LIFT TIPPED INTO THE TUBE. THE RESIDENT SUSTAINED A LACERATION ON LEFT FOREHEAD ON WHICH A "STERIL STRIP" WAS APPLIED.

    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 75 YR