BEUDAMED
    FDA Adverse Event Other Summary report: N

    MRL -MEDICAL RESEARCH LABORATORIES-

    MDR report key: 746420 · Received October 7, 2005

    Report

    Report Number
    MW1036892
    Event Type
    Other
    Date Received
    October 7, 2005
    Date of Event
    September 24, 2005
    Report Date
    October 7, 2005
    Manufacturer
    WELCH ALLYN
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AFTER ATTACHING MRL MONITOR ELECTRODES TO PATIENT PRESENTING WITH GENERAL WEAKNESS AND MALAISE AT A NURSING HOME, THE MESSAGE ON THE MONITOR READ LEAD FAULT, AND NO RHYTHM ANALYSIS WAS POSSIBLE BY THE ATTENDING FIRST RESPONDERS. ACCORDING TO THE CAPTAIN IN CHARGE, THE LEADS WERE THEN CHECKED WITHOUT CHANGE ON THE MONITOR. THERE WAS AN AMBULANCE THAT RESPONDED 3 MINUTES LATER AND TOOK OVER THE CALL, USING ANOTHER MRL MONITOR WHICH FUNCTIONED WITHOUT ERROR. THE RHYTHM RECORDED OF THE PATIENT WAS NORMAL SINUS RHYTHM. THE ABOVE MALFUNCTION EVENT DID NOT APPEAR TO HAVE ANY ADVERSE EFFECTS FOR THE PATIENT, AND THE CORRESPONDING MONITOR WAS SENT BACK TO MRL FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRL -MEDICAL RESEARCH LABORATORIES- DEFIBRILLATOR MKJ WELCH ALLYN PIC50 *

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other