BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFORMATION CENTER NETWORK DATABASE

    MDR report key: 1691818 · Received May 12, 2010

    Report

    Report Number
    1218950-2010-00711
    Event Type
    Death
    Date Received
    May 12, 2010
    Report Date
    April 28, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K011093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEY DID NOT HEAR AN AUDIBLE ALARM AT THE CENTRAL STATION, RESULTING IN THE DEATH OF A PT. A FIELD SERVICE ENGINEER (FSE) FROM THE DISTRIBUTOR WENT ON SITE TO OBTAIN LOGS AND TEST THE DEVICE. HE SIMULATED ALARMS AT THE CENTRAL STATION AND WITH THE TELEMETRY TRANSMITTER AND CONFIRMED THE DEVICES WERE WORKING TO SPECIFICATIONS. A REVIEW OF THE CENTRAL STATION ALARM LOGS INDICATED THAT ON (B) (6) 2010 BEGINNING AT 23:26:46 UNTIL (B) (6) 2010, 01:14:40, THERE WERE 8 VTACH 1, 1 BRADY, 8 VFIB/TACH (ONE OF WHICH ANNUNCIATED FOR 6 MINS UNTIL IT WAS ESCALATED TO AN ASYSTOLE) AND 2 ASYSTOLE (ONE OF WHICH ANNUNCIATED FOR 5 MINS UNTIL IT WAS SILENCED) ALARMS, WHICH WERE SILENCED BY THE USER. AT THE 00:44 TIME GIVEN AS THE TIME OF THE ASYSTOLE INCIDENT, THE CENTRAL STATION ALARM LOGS SHOW AN ASYSTOLE ALARM THAT WAS SILENCED AT THE CENTRAL STATION AND THEN THE MONITOR RE-ALARMED FOR BRADY. ALARMING AND ACKNOWLEDGEMENT OF ALARMS IS ADEQUATELY DESCRIBED IN THE PRODUCT LABELING (IFU). THE AVAILABLE INFO DOES NOT SUPPORT THAT THERE WAS A MALFUNCTION, DESIGN OR LABELING PROBLEM, BUT AN ISSUE DUE TO THE SILENCING OF ALARMS BY THE USER WITHOUT PROVIDING THERAPY WARRANTED FOR THIS PT. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT WENT INTO ASYSTOLE, AND THERE WAS NO AUDIBLE ALARM AT THE CENTRAL STATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFORMATION CENTER NETWORK DATABASE MHX, DRT MHX PHILIPS MEDICAL SYSTEMS M3155B

    Patients

    Seq Age Sex Outcome Treatment
    1 Death