BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS INFORMATION CENTER

    MDR report key: 5041713 · Received August 31, 2015

    Report

    Report Number
    1218950-2015-04683
    Event Type
    Death
    Date Received
    August 31, 2015
    Date of Event
    August 18, 2015
    Report Date
    August 18, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K011093
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEY DID NOT RECEIVE AN ALARM FROM THEIR MX40 DEVICE FOR ***VTACH. THE CUSTOMER WAS NOT FORTHCOMING WITH INFORMATION RELATED TO THIS INCIDENT OR LOGS. BASED ON THE LIMITED INFORMATION AT THIS TIME, WE WILL REPORT THIS INCIDENT. INITIALLY THERE WAS NO PATIENT HARM REPORTED BY THE CUSTOMER. ON 09/08/15, THE ATTORNEY FOR THE CUSTOMER DID CONFIRM THAT THERE WAS A DEATH ASSOCIATED WITH THIS CALL. THE TYPE OF REPORTED COMPLAINT WAS CHANGED FROM NON-ADVERSE EVENT TO DEATH. A REVIEW OF THE PROVIDED WAVE REVIEW STRIPS INDICATED THAT ON (B)(6) 2015 @00:28 FOR ROOM 800A, THERE IS INDICATION OF AN INOP PERIOD LABELLED "I." THERE IS THEN INDICATION OF LEARNING OCCURRING, LABELLED "L." THE ALGORITHM THEN LABELLED ALL BEATS WHICH OCCURRED AFTER THE LEARNING PERIOD AS "N" FOR NORMAL. A REVIEW OF THE CENTRAL STATION ALARM LOGS INDICATED THAT ON (B)(6) 2015 FOR ROOM 800A FROM 00:30 UNTIL 07:59, THERE WERE NUMEROUS *AFIB, *MULTIFORM PVCS, PVCS >10/MIN, PAIR PVCS ALARMS, SEVERAL OF WHICH WERE SILENCED AT THE CENTRAL STATION. BEGINNING @08:03 UNTIL 08:20, THERE WERE 3 ***VFIB/TACH AND 2 ***ASYSTOLE ALARMS WHICH WERE ALSO SILENCED AT THE CENTRAL STATION. THERE ARE ALSO SEVERAL TECHNICAL ALARMS FOR "LEADS OFF" "LEADSET UNPLUGGED" AND "CANNOT ANALYZE ECG" ALARMS. THE INFORMATION IS NOT CONSISTENT WITH A MALFUNCTION OF THE PRODUCT. THE FIELD SERVICE ENGINEER WAS INFORMED BY THE BIOMEDICAL ENGINEER THAT THEY DID NOT REQUIRE ANYTHING ELSE FROM PHILIPS REGARDING THIS ISSUE. THE CUSTOMER REMOVED THE PC OUT OF SERVICE AND THE FIELD SERVICE ENGINEER ASSISTED THE BIOMEDICAL ENGINEER WITH THE RELOAD AND CONFIGURATION OF THE SPARE PC TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY DID NOT RECEIVE AN ALARM FROM THEIR MX40 DEVICE FOR ***VTACH. THERE WAS NO PATIENT HARM REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY DID NOT RECEIVE AN ALARM FROM THEIR MX40 DEVICE FOR ***VTACH AT THE CENTRAL STATION. ON 09/08/15, THE ATTORNEY FOR THE CUSTOMER DID CONFIRM THAT THERE WAS A DEATH ASSOCIATED WITH THIS CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575813 PHILIPS INFORMATION CENTER CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS M3150B

    Patients

    Seq Age Sex Outcome Treatment
    1 Death