BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON

    MDR report key: 11147013 · Received January 11, 2021

    Report

    Report Number
    1825014-2021-00003
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    October 22, 2020
    Report Date
    January 11, 2021
    Manufacturer
    GCX CORPORATION
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE VST ACCESSORY CLAMP WAS STRIPPED WHERE THE GCX VHM MONITOR ARM ATTACHES TO THE SCREWS. THIS WAS CAUSED BY AN OVER ADJUSTMENT OF THE 4 SET SCREWS THAT KEEP THE GCX VHM MONITOR ARM FIRMLY ATTACHED TO THE VST CLAMP. THE SET SCREWS WERE SO FIRMLY ADJUSTED THAT THEY CARVED GROOVES INTO THE STAINLESS STEEL HOUSING AND THEN CAUSED 2 OF THE SET SCREWS TO BE STRIPPED AND ARE UNABLE TO BE REMOVED AS INTENDED. THIS OVER ADJUSTMENT IN ADDITION TO TRAUMA TO THE ASSEMBLY AS A WHOLE IS WHAT CAUSED THE FAILURE TO OCCUR. I WAS ABLE TO ENSURE THAT THE MALFUNCTION DID NOT EFFECT THE MONITOR OR MONITOR WIRING. THE MONITOR STILL SHOWS PICTURE AND FUNCTIONS PROPERLY. OR 20 SN (B)(4) I REPLACED THE VST ACCESSORY CLAMP, (H8­300­39­A), ON THE VST. I ATTACHED THE GCX MOUNTING BLOCK FOR CLAMP, (H8­300­40­B) AND SECURED A NEW GCX VARIABLE HEIGHT ARM, (H8­010­50­A), WITH DOWN POST KIT, (H8­010­50­01). I ATTACHED THE MONITOR AND RE­RAN THE CABLES AND MADE THE APPROPRIATE CONNECTIONS. I SUCCESSFULLY TESTED THE SIGNAL TO THE MONITOR AND ENSURED IT WAS SECURE.

    Description of Event or Problem · 1

    SKYTRON COMPLAINT NUMBER: (B)(4). A MONITOR AND MONITOR BRACKET DETACHED FROM THE VST CLAMP THAT IT MOUNTS TO. THE VST ACCESSORY CLAMP WAS STRIPPED WHERE THE GCX VHM MONITOR ARM ATTACHES TO THE SCREWS. THIS WAS CAUSED BY AN OVER ADJUSTMENT OF THE 4 SET SCREWS THAT KEEP THE GCX VHM MONITOR ARM FIRMLY ATTACHED TO THE VST CLAMP. THE SET SCREWS WERE SO FIRMLY ADJUSTED THAT THEY CARVED GROOVES INTO THE STAINLESS STEEL HOUSING AND THEN CAUSED 2 OF THE SET SCREWS TO BE STRIPPED AND ARE UNABLE TO BE REMOVED AS INTENDED. THIS OVER ADJUSTMENT IN ADDITION TO TRAUMA TO THE ASSEMBLY AS A WHOLE IS WHAT CAUSED THE FAILURE TO OCCUR. I WAS ABLE TO ENSURE THAT THE MALFUNCTION DID NOT EFFECT THE MONITOR OR MONITOR WIRING. THE MONITOR STILL SHOWS PICTURE AND FUNCTIONS PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47476 SKYTRON VHM WALL MOUNT NEW 8/20.3 EXT. EXTENSION ARM FQO GCX CORPORATION H8-010-50-A

    Patients

    Seq Age Sex Outcome Treatment
    1