BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI MERLIN

    MDR report key: 561508 · Received January 13, 2004

    Report

    Report Number
    561508
    Event Type
    Malfunction
    Date Received
    January 13, 2004
    Date of Event
    December 10, 2003
    Report Date
    January 13, 2004
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT RECENTLY HAD HAD AN MI MYOCARDIAL INFARCTION AND WAS EXPECTED TO DIE SOON AND SO WAS CLASSIFIED DNR/DNI DO NOT RESUSCITATE/DO NOT INTUBATE. IN SPITE OF THIS THE PATIENT WAS PLACED ON A PORTABLE BEDSIDE MONITOR. PRIOR TO THE PATIENT'S DEATH THE MONITOR'S ALARMS WERE SUSPENDED WHILE A ROUTINE NURSING TASK WAS CARRIED OUT. THE ALARMS DID NOT AUTOMATICALLY REVERT TO THE DESIRED UNSUSPENDED STATE THUS NEITHER THE CENTRAL STATION NOR THE MONITOR ALARMED WHEN THE PATIENT WENT INTO TERMINAL VF VENTRICULAR FIBRILLATION. IT TURNED OUT THAT THIS MONITOR HAD BEEN SENT TO THE MANUFACTURER FOR REPAIR. "UNBEKNOWNST" TO THE NURSING OR CLINICAL ENGINEERING STAFF WHEN IT WAS RETURNED ITS DEFAULT SETTING FOR ALARMS SUSPENDED HAD BEEN CHANGED FROM AN INSTITUTION-STANDARD 3 MINUTES TO THE FACTORY DEFAULT "INFINITE" SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI MERLIN PHYSIOLOGICAL MONITOR MHX PHILIPS MEDICAL SYSTEMS, INC. M1205A *

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR