BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOUNT

    MDR report key: 18123401 · Received November 9, 2023

    Report

    Report Number
    MW5148061
    Event Type
    Injury
    Date Received
    November 9, 2023
    Date of Event
    November 6, 2023
    Report Date
    November 7, 2023
    Manufacturer
    GCX CORPORATION
    Product Code
    QWA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS LETTER IS TO INFORM YOU THAT GE HEALTHCARE (GEHC) RECEIVED A COMPLAINT FROM (B)(6) REPORTING THAT A NURSE SUSTAINED A SHOULDER INJURY WHILE ATTEMPTING TO CATCH A FALLING GE HEALTHCARE (GEHC) PATIENT MONITOR. THE CUSTOMER COULD NOT PROVIDE ANY FURTHER DETAILS PERTAINING TO THE EXTENT OF THE NURSE¿S INJURY AND ANY TREATMENT THAT MAY HAVE BEEN REQUIRED. THE CUSTOMER SUBSEQUENTLY DETERMINED THAT THE GCX MOUNT HAD FAILED THUS CAUSING THE GEHC MONITOR TO FALL. THE GCX MOUNT IS NOT MANUFACTURED BY GEHC. THE MOUNT IS MANUFACTURED BY GCX MOUNTING SOLUTIONS, WHO¿S AMERICAN OPERATIONS ARE IN (B)(6). GEHC NOTIFIED GCX MOUNTING SOLUTIONS OF THE EVENT ON (B)(6) 2023. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989351 MOUNT CARDIOVASCULAR DELIVERY CATHETER SYSTEM POSITIONING AND STABILIZATION DEVICE QWA GCX CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown