BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEWLETT PACKARD (NOW PHILLIPS)-"MOR

    MDR report key: 428525 · Received November 12, 2002

    Report

    Report Number
    MW1026748
    Event Type
    Death
    Date Received
    November 12, 2002
    Date of Event
    October 25, 2002
    Report Date
    November 12, 2002
    Manufacturer
    *
    Product Code
    DRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILURE OF HEWLETT PACKARD ECG MONITOR ALARMS TO OPERATE WHERE PATIENT BECAME BRADY CARDIC-RESULTED IN PROLONGED PERIOD OF ASYSTOLE BEFORE RESUSCITATION WAS BEGUN. INVESTIGATION SUBSEQUENT TO THIS EVENT HAS DETERMINED THAT THERE IS A POTENTIAL DESIGN FLOW WITHIN THE SOFTWARE WHICH RESULTED IN THE NURSE INADVERTIENTLY DISABLING ALL ALARMS.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 3/3/03: THE CUSTOMER REPORTED TO PHILIPS MEDICAL, VIA A PHONE CALL TO THE FIELD SERVICE ENGINEER (FSE), THAT THE PT'S HEART RATE WENT TO 0 BPM AND THE MONITOR ALLEGEDLY DIDN'T ALARM. THE CUSTOMER REQUESTED THAT A PHILIPS FIELD SERVICE ENGINEER CHECK THE DEVICE. SUMMARY: THE CO'S INVESTIGATION FOUND THAT THE USER HAD DISABLED THE ALARMS PRIOR TO THE EVENT. THE PT CODED, BUT SURVIVED. WITH THE ASSISTANCE OF THE HOSPITAL BIOMEDICAL ENGINEER, PHILIPS DETERMINED THE M1176A BEDSIDE MONITOR ALARMS WERE OFF AT THE TIME OF THE INCIDENT. THE PT CODED WHILE THE ALARMS WERE IN THIS DISABLED STATE. HOWEVER, THE VISUAL 'ALL ARRH ALRMS OFF' INOP AND STATUS MESSAGES DISPLAYED APPROPRIATELY. THE CO'S INVESTIGATION: DEFAULT CONFIGURATION WHEN SHIPPED: THE BEDSIDE MONITOR IS CONFIGURED WITH HR ALARMS LIMITS 50 150*; ALARM BEHAVIOR-NON-LATCHING; ALARM REMINDER ON WITH 3-MINUTES DURATION; VISUAL LATCHING OFF; HR AS THE ALARM SOURCE*; PULSE SOURCE ABP*; HR ALARM ON/OFF-ENABLED. THE USER CAN CHANGE THE SETTINGS IDENTIFIED WITH AN *. THE CUSTOMER ALSO HAS AN AGILENT INFO CENTER CENTRAL STATION, WHICH PROVIDES ARRHYTHMIA DETECTION AND ALARMING FOR THE ECG SIGNAL TRANSMITTED FROM THE BEDSIDE MONITOR. HOWEVER, THE AGILENT INFO CENTER WILL NOT PROVIDE ECG ARRHYTHMIA DETECTION AND ALARMING IF THE ALARM SOURCE AT THE BEDSIDE IS SET TO "PULSE" OR THE BEDSIDE HEART RATE ALARM IS TURNED OFF. INSTEAD, THE AGILENT INFO CENTER WILL DISPLAY THE INOP 'ALL ARRH ALRMS OFF'. INCIDENT: THE LOGS INDICATE THAT FOR THIS PT, ARRHYTHMIA DETECTION WAS OFF AND THE ALARMS WERE NOT SUSPENDED AT THE TIME OF THE INCIDENT. THESE FINDINGS ARE CONSISTENT WITH THE USER EITHER CHANGING THE ALARM SOURCE TO "PULSE" OR TURNING OFF THE HR ALARMS ENTIRELY AT THE BEDSIDE. BECAUSE THE PT DID NOT HAVE AN ARTERIAL LINE, EITHER SETTING WOULD HAVE DISABLED THE HEART RATE ALARMS, ALTHOUGH THERE WOULD BE MULTIPLE VISUAL INDICATORS THAT THE ALARMS WERE OFF. POST INCIDENT: IN SEPT 2002 AT 9:35:47 THE ALARMS WERE SUSPENDED AND WERE AUTOMATICALLY UNSUSPENDED THREE MINUTES LATER. AT 9:52:10 THE ARRHYTHMIA ALARMS WERE TURNED BACK ON. THE PHILIPS CE WAS NOTIFIED OF THE INCIDENT AT 16:30. THE PHILIPS CE CONDUCTED PERFORMANCE AND ALARM FUNCTION TESTS, WHICH TESTED TO SPECIFICATIONS. CO'S CE WAS PROVIDED WITH LOG FILES BUT WAS NOT ABLE TO OBTAIN THE STRIP RECORDINGS OR DATA PRINTOUTS RELEVANT TO THE INCIDENT. THE PHILIPS CLINICAL SPECIALIST RECEIVED A CALL FROM THE HOSPITAL ON OCT 31, 2002 TO DISCUSS THE ALARM BEHAVIOR OF THE BEDSIDE MONITOR. THE DISCUSSION RESOLVED AROUND THE FUNCTIONALITY OF HR/PULSE AS ALARM SOURCES, AND THEIR INTERACTION WITH ARRHYTHMIA MONITORING. THE HOSPITAL DID NOT UNDERSTAND THAT WITH PULSE AS THE ALARM SOURCE, ARRHYTHMIA DETECTION AND ALARMING WAS DISABLED, DESPITE THE PRESENCE OF THE 'ALL ARRH ALRMS OFF' MESSAGE. CONCLUSION: BASED ON THE ABOVE INVESTIGATION AND A SITE VISIT BY THE PHILIPS CLINICAL SPECIALIST, CO DETERMINED THAT THE HOSPITAL CLINICIAN HAD TURNED OFF THE HEART RATE AND ARRHYTHMIA ALARMS FOR THIS PT BY SWITCHING THE ALARMING SOURCE FROM 'HR' TO 'PULSE', WHEN NO PULSE SOURCE WAS PRESENT ON THE PT. THE HOSPITAL CLINICIAN DID NOT EXPLORE THE MEANING OF THE 'ALL ARRH ALRMS OFF' INOP MESSAGE WHICH WAS DISPLAYED IN THE PT SECTOR AT THE INFO CENTER AND AT THE BEDSIDE MONITOR. AN INSPECTION OF THE DEVICE SUBSEQUENT TO THE INCIDENT USING A SIMULATOR TO GENERATE ALARMS, CONFIRMED THAT THE DEVICE WAS OPERATING APPROPRIATELY. ALARM BEHAVIOR IS BEING DISCUSSED WITH THE HOSPITAL. THE DATE THE FIRM RECEIVED INFO ABOUT THIS EVENT WAS OCTOBER 25, 2002. THERE WAS NO DEATH OR SERIOUS INJURY FOR THIS INCIDENT. THE DEVICE IN QUESTION CONTINUES TO BE USED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEWLETT PACKARD (NOW PHILLIPS)-"MOR BEDSIDE ECG MONITOR DRT * M1176A *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death