BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL DATA ELECTRONICS (MDE)

    MDR report key: 370021 · Received December 17, 2001

    Report

    Report Number
    370021
    Event Type
    Malfunction
    Date Received
    December 17, 2001
    Date of Event
    December 1, 2001
    Report Date
    December 17, 2001
    Manufacturer
    MDE
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT BEING MONITORED AFTER CONSCIOUS SEDATION. MONITOR BEGAN READING SVT OR V-FIB. PT FOUND TO BE IN NO DISTRESS. PLEASE TAKE NOTE THAT STRIP INDICATED HR OF 82 BEATS PER MINUTES. PT NOT INJURED. STAFF TREATED BASED ON CLINICAL FINDINGS. STRIP REPRINTOUT OF EVENT WITH NO VF/SVT. NURSE QUESTIONS CELL PHONE INTERFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56873 MEDICAL DATA ELECTRONICS (MDE) ESCORT VISION CENTRAL STATION DRT MDE VISION-20500-16 1.3.0

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other SOFTWARE UPGRADE PROVIDED 12/06/2001 TO CLIMINATE| PROBLEM.