BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARJO

    MDR report key: 1052131 · Received May 22, 2008

    Report

    Report Number
    MW5007012
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 22, 2008
    Product Code
    FPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PLEASE NOTE VANJHCS HAS INTERNALLY IDENTIFIED A HAZARDOUS ISSUE WITH THE ARJO TROLLEY SHOWER LIFT DUE TO PRODUCT FAILURE. PRODUCT IDENTIFIED AS: MANUFACTURER: ARJO HOSPITAL EQUIPMENT. EQUIPMENT NAME: ARJO SHOWER TROLLEY, EQUIPMENT TYPE: LIFT, BATH PATIENT. MODEL # 08400004, ACQUISITION DATE: JUNE 1988. NATURE OF PROBLEM: A PATIENT WAS BEING LIFTED WITH THE ARJO LIFT WHEN THE LIFT BROKE CAUSING THE PATIENT TO FALL. THE EMPLOYEE OPERATING THE LIFT WAS INJURED. IT APPEARS THE BOLTS SNAPPED AND THE TOP STRETCHER PART SNAPPED FROM THE HYDRAULIC CYLINDER. ACTION TAKEN: ACTION WAS INITIATED TO IDENTIFY AND REMOVE THE HAZARDOUS ARJO LIFT FROM USE. FIVE -5- ADDITIONAL ARJO LIFTS WERE IDENTIFIED IN THE NURSING HOME CARE UNIT, PHYSICALLY CHECKED AND THE BOLTS IN QUESTION WERE REPLACED WITH NEW GRADE 8 HARDENED BOLTS USING THREAD LOCK SEALANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARJO ARJO SHOWER TROLLEY FPO 084000004

    Patients

    Seq Age Sex Outcome Treatment
    1