BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GCX WALL MOUNTED MONITOR STAND

    MDR report key: 14345979 · Received May 9, 2022

    Report

    Report Number
    MW5109610
    Event Type
    Injury
    Date Received
    May 9, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 6, 2022
    Manufacturer
    UNK
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A COLONOSCOPY IN AN AMBULATORY SURGERY CENTER, A MINDRAY MONITOR BECAME DISLODGED FROM ITS WALL STAND WHILE A CRNA WAS REPOSITIONING THE MONITOR AND FELL ON A PATIENT'S HEAD. PATIENT SUFFERED SCALP LACERATION AND WAS SENT TO THE LOCAL HOSPITAL ER FOR EVALUATION AND TREATMENT AS NECESSARY. FDA SAFETY REPORT IDS# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569526 GCX WALL MOUNTED MONITOR STAND TABLE, OPERATING-ROOM, AC-POWERED FQO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization MINDRAY PORTABLE PATIENT MONITOR