BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECAREMANAGER SYSTEM

    MDR report key: 7513903 · Received May 15, 2018

    Report

    Report Number
    1125873-2018-00001
    Event Type
    Death
    Date Received
    May 15, 2018
    Date of Event
    April 13, 2018
    Report Date
    April 16, 2018
    Manufacturer
    VISICU, INC - DUP
    Product Code
    MSX
    UDI-DI
    00884838059832
    PMA / PMN Number
    K153156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING SUBMISSION OF THE INITIAL FOLLOW UP, WE, PHILIPS, SENT A THIRD REQUEST TO OBTAIN INFORMATION REGARDING THE INTERNAL INVESTIGATION BY (B)(6) MEDICAL CENTER ON JUNE 28, 2018. IN A RESPONSE ALSO DATED JUNE, 28, 2018 WE WERE INFORMED THAT THERE WERE NO UPDATES AT THAT TIME. AT THIS TIME WE CONSIDER THE MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    FOLLOWING SUBMISSION OF THE INITIAL EMDR WE, PHILIPS, HAVE ENDEAVORED TO OBTAIN INFORMATION REGARDING THE INTERNAL INVESTIGATION BY (B)(6) MEDICAL CENTER. TO THAT END WE HAVE SEND REQUESTS FOR MORE INFORMATION ON MAY 17, 2018 AND JUNE 1, 2018. IN RESPONSES DATED MAY 18, 2018 AND JUNE 1, 2018 WE WERE INFORMED THAT THERE WERE NO UPDATES AT THAT TIME. WE WILL CONTINUE TO MONITOR FOR A FURTHER RESPONSE AND WILL UPDATE AS INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE PRELIMINARY INVESTIGATION INTO THE EVENTS OF (B)(6) 2018, BY PHILIPS, REVEALED THE FOLLOWING INFORMATION. AT 1:42 AM ¿ VITAL SIGNS MESSAGE DATA STOPPED FOR THE PATIENT. AT 1:45 AM ¿ BP VALUES RECEIVED FOR THE FINAL TIME. AT 1:51 AM ¿ VITALS STOPPED NOTIFICATION WAS SENT TO ALL RUNNING WORKSTATIONS. THIS NOTIFICATION WAS NOT DISMISSED AND REMAINED ON SCREEN FOR AN HOUR BEFORE BEING AUTO-DISMISSED BY THE SYSTEM. AT 3:27 AM ¿ HEART RATE DATA RECEIVED. AT 3:47 AM ¿ PATIENT WAS DISCHARGED FROM THE EICU SYSTEM DUE TO THEIR PASSING. DURING THE TIME BETWEEN MEASUREMENT, MESSAGES WERE RECEIVED BUT CONTAINED NO VALUES TO POST. THIS PATIENT WAS A LOW ACUITY PATIENT AND WAS ON AN INFREQUENT ROUNDING SCHEDULE BY THE EICU STAFF. WHEN THE EICU NURSE DID ROUND ON THE PATIENT, USING THE IN ROOM AUDIO/VISUAL EQUIPMENT, THE NURSE NOTICED THAT THE PATIENT WAS UNRESPONSIVE AND THAT PATIENT MONITORING LEADS WERE OFF THE PATIENT AND COULD BE SEEN LYING ON THE BED. THE NURSE THEN CONTACTED THE BEDSIDE STAFF AND RELAYED THEIR FINDINGS. PHILIPS PRELIMINARY INVESTIGATION CONCLUDES THAT THE EICU SYSTEM PERFORMED AS DESIGNED. THIS DEVICE IS NOT USED IN THE TREATMENT OR DIAGNOSIS OF PATIENTS, ACCORDING TO THE DEVICE'S INTENDED USE. CONTRARY TO THE CUSTOMER REPORT, THE VITALS STOPPED NOTIFICATION WAS SENT. IN ADDITION, THE PROOF OF PERFORMANCE IS SHOWN BY THE CONTINUED RECEIPT OF MESSAGES CONTAINING NO DATA VALUES, AND THE RECEIPT OF VITAL DATA AT 3:27 AM. AT THE CURRENT TIME THE CUSTOMER IS PERFORMING AN INTERNAL INVESTIGATION INTO THIS INCIDENT. THE RESULTS OF THIS INVESTIGATION WILL BE TRANSMITTED TO PHILIPS ONCE THEY ARE AVAILABLE. FOLLOWING THIS PHILIPS WILL SEND UPDATES OR FURTHER SUBMISSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357691 ECAREMANAGER SYSTEM ECAREMANAGER MSX VISICU, INC - DUP 865325 N/A 00884838059832

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR