BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VHM SERIES VARIABLE HEIGHT MOUNT (WS01)

    MDR report key: 6345378 · Received February 21, 2017

    Report

    Report Number
    6345378
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Date of Event
    November 25, 2016
    Report Date
    January 30, 2017
    Manufacturer
    GCX CORPORATION
    Product Code
    FOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MONITOR DROPPED FROM LOCKED POSITION AND HIT STAFF MEMBER'S HEAD. THE VHM ARTICULATING ARM CONNECTED TO THE PHILIPS MONITOR LOCK LEVER RELEASED DUE TO A INTERNAL GAS SPRING WHICH HAD LOST ITS GAS CHARGE. IN CASES WHERE THE ARM IS LEFT UNUSED AND UNCHECKED FOR MANY MONTHS, GRADUAL LOSS OF PRESSURE MAY NOT BE NOTICED UNTIL THE LOCKING LEVER IS RELEASED. MANUFACTURER RESPONSE FOR ARTICULATING MOUNT ARM, VHM ARTICULATING MOUNT ARM FOR PHILIPS MONITOR (PER SITE REPORTER). GCX BULLETIN HAD BEEN SENT OUT TO THE IDENTIFIED OWNERS. PRIMARY CHILDRENS' HOSPITAL CLINICAL ENGINEERING HAD NOT RECEIVED NOTICE. PHILIPS HAD INSTALLED THIS MOUNT WITH THE MONITORS THAT PRIMARY HAD PURCHASED FROM THEM, SO PRIMARY WAS NOT IDENTIFIED AS A OWNER BUT PHILIPS WHO HAD PURCHASED FOR INSTALLATION OF THEIR MONITORS IN THE UNITS. COMMUNICATION WAS NOT PASSED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129285 VHM SERIES VARIABLE HEIGHT MOUNT (WS01) STAND, INFUSION FOX GCX CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other