BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUNINO NEURO CARE INC

    MDR report key: 148075 · Received January 9, 1998

    Report

    Report Number
    148075
    Event Type
    Malfunction
    Date Received
    January 9, 1998
    Date of Event
    July 15, 1997
    Report Date
    July 18, 1997
    Manufacturer
    CUNINO NEURO CARE INC
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH ICP MONITOR IN PLACE. PT TRANSFERRED FROM CART TO CT TABLE-ICP MONITOR INTACT AND MONITORED DURING TRANSFER. AFTER TRANSFER, PLASTIC CONNECTION FOUND TO BE BROKEN AT HUB. CATHETER REMOVED. PT W/NO HARM. CONDITION UNCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUNINO NEURO CARE INC COMPLETE OLM INTRACRANIAL PRESSURE MONITOR GWM CUNINO NEURO CARE INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR