BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 4213427 · Received October 22, 2014

    Report

    Report Number
    9681684-2014-00078
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 25, 2014
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO MED. (B)(4) LTD. 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 ARJOHUNTLEIGH (B)(4) AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #(B)(4). (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION. REFERENCE IMPORTER # (B)(4).

    Description of Event or Problem · 1

    ARJOHUNTLEIGH RECEIVED A COMPLAINT WHERE IT WAS REPORTED THAT DURING THE RESIDENT'S TRANSFER FROM THE BED TO THE COMMODE CHAIR, THE TEMPO PASSIVE FLOOR LIFT BEGAN TO TIP WHILE PULLING THE LIFT AWAY FROM THE BED AND ATTEMPTING TO MANEUVER THE LIFT FACE THE COMMODE CHAIR. THE HOIST WAS STABILIZED BY ONE OF THE CAREGIVERS PRESENT BEFORE IT FELL. A CAREGIVER WAS HURT DURING THE TIPPING, BUT WAS ABLE TO STAND THE LIFT UPRIGHT. THE RESIDENT WAS NOT INJURED. THE CAREGIVER SUSTAINED BRUISES TO THE HEAD AND SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671041 TEMPO FSA ARJO MED AB LTD. KPA50120

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other