BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER

    MDR report key: 2192415 · Received June 24, 2011

    Report

    Report Number
    1218950-2011-01014
    Event Type
    Death
    Date Received
    June 24, 2011
    Date of Event
    March 26, 2011
    Report Date
    March 31, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THERE WAS NO AUDIBLE SOUND AT THE CENTRAL STATION FROM ONE BED FOR A NUMBER OF MINUTES. A PHILIPS FIELD SERVICE ENGINEER WENT ON SITE TO TROUBLESHOOT THE CAUSE OF THE ISSUE AND OBTAIN ALARM LOGS FROM THE CENTRAL STATION. A REVIEW OF THE CENTRAL STATION ALARM LOGS FOR THIS PT INDICATED THAT ON (B)(6) 2011 AT 08:33:00 UNTIL 09:46:10, THERE WERE 20 DESAT, 6 FIB/TACH AND 3 ASYSTOLE ALARMS, MANY OF WHICH WERE SILENCED BY THE USER. BEFORE 9:00, THE ALARMS WERE SILENCED AT THE CENTRAL STATION. AFTER 9:00, THE ALARMS WERE SILENCED EITHER AT THE BEDSIDE MONITOR OR AT A CENTRAL STATION CLIENT. NOTE THAT THE SEQUENTIAL REPETITION OF THE SAME ALARM IN THE ALARM LOG CONFIRMS THAT THE ALARM HAS BEEN ACKNOWLEDGED. THERE IS ALSO INDICATION THAT ALARMS WERE SUSPENDED 6 TIMES, EACH TIME AUTOMATICALLY COMING OUT OF SUSPENSION AFTER 3 MINUTES. NO STRIPS WERE PROVIDED FOR REVIEW. POST INCIDENT TESTING INDICATED THAT THE DEVICE WAS WORKING AS INTENDED/DESIGNED. LATER INFO PROVIDED TO PHILIPS INDICATED THAT THIS PT HAD DIED. THE AVAILABLE INFO DOES NOT SUPPORT THAT THERE WAS A DESIGN, MALFUNCTION, OR LABELING PROBLEM, BUT AN ISSUE DUE TO SILENCING ALARMS BY THE USER. INFO PERTAINING TO ALARMS IS FULLY EXPLAINED IN THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT. CONSIDERATION OF THIS COMPLAINT AND SIMILAR COMPLAINTS SUPPORTS THAT THERE ARE NO DESIGN, MFG, MATERIALS, OR LABELING PROBLEMS. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS NO AUDIBLE SOUND AT THE CENTRAL STATION DURING AN ALARM EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE INFORMATION CENTER MHX PHILIPS HEALTHCARE - ANDOVER M3150

    Patients

    Seq Age Sex Outcome Treatment
    1 Death