BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONCERTO, BASIC & SHOWER TROLLEY

    MDR report key: 2015716 · Received March 1, 2011

    Report

    Report Number
    9611530-2011-00019
    Event Type
    Other
    Date Received
    March 1, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT (B)(4) WILL BE REPORTED BY US, THE LEGAL MFR, ARJO HOSPITAL EQUIPMENT (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, ARJOHUNTLEIGH INC., (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER ON (B)(6) 2011: PT FELL TO FLOOR BY THE STRETCHER FLIPPED TO SIDE SUDDENLY. THE STRETCHER WAS NOT LOCKED DUE THE HORIZONTAL LEVER WERE NOT WORKING PROPERLY (THE LEVER FELL DOWN). BEFORE THEY LOADED UP THE PT, THE USER FLIPPED DOWN THE STRETCHER BUT DIDN'T NOTICE THAT THE STRETCHER WAS NOT LOCKED PROPERLY. THE STRETCHER WAS BLOCKED BY THE P/N 8352659 EXCENTER DUE TO MALFUNCTION OF THE P/N 8421810 SPRING. THE TROLLEY IS UNDER THE MAINTENANCE BY THE GOVERNMENT DEPT - ELECTRICAL AND MECHANICAL SERVICE DEPARTMENT. ALL ROUTINE CHECK AND REPAIR WORK WAS HANDLED BY THEM. COMMENT BY SSU: THE MALFUNCTION OF THE HORIZONTAL LEVER DEVICE HAS BEEN SEEN SOMETIMES DURING OUR ROUTINE CHECK. IT IS CAUSED BY THE LOOSEN OF THE P/N 6190087 STOP SCREW. THEN THE P/N 8421810 SPRING RELEASED FROM THE TENSION BY THE MOVEMENT OF THE P/N8352683 MOUNTING BLOCKS. WHILE THE SPRING FAILED, THE LEVER FALL DOWN AND THE P/N EXCENTER MAY HAVE BLOCKED THE LOCKING OF STRETCHER. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO, BASIC & SHOWER TROLLEY LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB 084*

    Patients

    Seq Age Sex Outcome Treatment
    1