BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-LAB

    MDR report key: 6559704 · Received May 11, 2017

    Report

    Report Number
    6559704
    Event Type
    Malfunction
    Date Received
    May 11, 2017
    Date of Event
    May 4, 2017
    Report Date
    May 8, 2017
    Manufacturer
    PARKS MEDICAL ELECTRONICS, INC.
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS A VASCULAR DOPPLER STUDY WAS IN THE PROCESS OF BEING INITIATED, A STAFF NURSE USING A TV REMOTE CONTROL "CLEAN REMOTE" TO TURN THE VOLUME OF THE TV DOWN, BUT THIS ACTUALLY CAUSED THE SCREEN DISPLAY TO CHANGE ON THE PARKS MODEL 2100 SX. CLINICAL ENGINEERING HAS SINCE TESTED THIS AND IN FACT DOES INDEED CHANGE THE SCREEN AND WILL FREEZE THE SCREEN ON THE PARK WHEN VARIOUS KEYS ARE PUSHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343587 FLO-LAB MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MWI PARKS MEDICAL ELECTRONICS, INC. 2100 SX

    Patients

    Seq Age Sex Outcome Treatment
    1 STANDARD ICU MONITOR AND IV PUMPSUNIVERSAL CLEAN