BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS TELEHEALTH SYSTEM

    MDR report key: 6489434 · Received April 13, 2017

    Report

    Report Number
    1125873-2017-00005
    Event Type
    Death
    Date Received
    April 13, 2017
    Date of Event
    April 2, 2017
    Report Date
    April 4, 2017
    Manufacturer
    VISICU, INC - DUP
    Product Code
    DRG
    PMA / PMN Number
    K023749
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS Q&R HAS INVESTIGATED THE REPORTED FAILURE OF ALERT FLAGS SPONTANEOUSLY CLEARING FOR A SINGLE PATIENT. THIS COMPLAINT HAS NOT BEEN CONFIRMED. INVESTIGATION REVEALED THAT ALL THE PATIENT¿S MEASUREMENTS ON (B)(6) 2017 WERE OUT OF RANGE AND GENERATING ALERT FLAGS. THESE ALERT FLAGS WERE ACKNOWLEDGED AND CLEARED WITH NO NOTES BY A SINGLE USER IDENTIFICATION AT THE CUSTOMER SITE. THE PHILIPS PATIENT TELEMONITORING SET IS WORKING AS DESIGNED. DURING THE COURSE OF THIS INVESTIGATION, PHILIPS BECAME AWARE THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY THE TELEHEALTH NURSE PERCEIVED THAT ALERT FLAGS WERE SPONTANEOUSLY CLEARED ((B)(6) 2017). PATIENT PASSED AWAY ON (B)(6) 2017 THOUGH THIS WAS NOT REPORTED BY THE CUSTOMER. THIS EVENT IS NOT RELATED TO ANY FAILURE OF A PHILIPS DEVICE. Q&R WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ALERT FLAGS FROM (B)(6) 2017 WERE SPONTANEOUSLY CLEARED FOR A SINGLE PATIENT USING THE PHILIPS PATIENT TELEMONITORING SET. TELEHEALTH NURSE WAS NOT AWARE OF THE ALERTS AND THERE WERE NO EVENT NOTES. PATIENT WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY ((B)(6) 2017) AND PASSED AWAY ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271988 PHILIPS TELEHEALTH SYSTEM PTS CUI DRG VISICU, INC - DUP M3810

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death