BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 2105013 · Received April 26, 2011

    Report

    Report Number
    9681684-2011-00030
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT WHILE 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 06/15/2010, 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). THE CLIP WAS FOUND TO BE CRACKED BUT IT CANNOT BE CONFIRMED IF THE CLIP WAS DAMAGED PRIOR TO THE TRANSFER. FURTHER INFO WILL BE PROVIDED UPON MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    WHILE THE NURSE WAS PUTTING THE PT BACK TO BED WITH AN AGENCY CARE ASSISTANT, SHE HAD DIFFICULTY WITH UNDER BED CLEARANCE, WHICH HELD UP, AND JUST BEFORE LANDING ON THE BED, ONE OF THE LEG CLIPS GAVE AWAY. THE PT DROPPED A SHORT DISTANCE ONTO THE BED. NO INJURIES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other