BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDE

    MDR report key: 353546 · Received September 25, 2001

    Report

    Report Number
    353546
    Event Type
    Malfunction
    Date Received
    September 25, 2001
    Date of Event
    September 14, 2001
    Report Date
    September 20, 2001
    Manufacturer
    MDE
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    SQUELCH BUILDUP IN PROCESSOR LEADS TO RECCURREING LOSS OF PT MONITORING (UP TO 6 MINUTES) FOR EACH PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43481 MDE TELEMETRY SYSTEM DRT MDE 20500-16 P/N 366000-0096

    Patients

    Seq Age Sex Outcome Treatment
    1 *