BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 7182167 · Received January 11, 2018

    Report

    Report Number
    9610816-2018-00012
    Event Type
    Death
    Date Received
    January 11, 2018
    Date of Event
    January 4, 2018
    Report Date
    January 8, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PRODUCT MALFUNCTION. THE ALARM LOG FROM THE PIIC CLASSIC USED FOR THIS MONITOR WAS REVIEWED BY THE RCE, AND ALSO A PHILIPS COMPLAINT INVESTIGATOR (CI) FOR THE REPORTED DATE AND TIME. BETWEEN 13:18 AND 15:30, MULTIPLE RED ALARMS OCCURRED, AND HAD BEEN SILENCED. PA SYSTO BASSE IS FOR A LOW ARTERIAL PRESSURE ALARM, WHICH IS A YELLOW ALARM. NO LOWER LEVEL YELLOW ALARMS WERE VISIBLE, AS THE PIIC CLASSIC DOES NOT RECORD THESE TYPES OF ALARMS ON THE ALARM LOG. THE LOWER LEVEL ALARMS WOULD ALSO NOT SOUND, IF A HIGHER RED ALARM WAS ALREADY ACTIVE. THE MONITOR ITSELF WAS NOT TESTED, AS THERE WAS NO ISSUE FOUND WITH THE DEVICE; THE DOCTOR HAD SEEN ALARMS ON THE DEVICE. THE RCE PROVIDED INFORMATION ON THE LOG ANALYSIS TO THE CUSTOMER. NO FURTHER COMMUNICATION HAS BEEN RECEIVED FROM THE CUSTOMER, AFTER PROVIDING THE INFORMATION. WE WILL CONSIDER THAT THE ISSUE WAS RESOLVED FOR THE CUSTOMER WITH THE INFORMATION PROVIDED BY THE RCE, AND THAT THE DEVICE REMAINS IN USE AT THE CUSTOMER SITE, AS NO SUBSEQUENT CALLS HAVE BEEN LOGGED FOR THIS DEVICE/ISSUE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR WANTED TO REVIEW THE ALARM HISTORY TO TRACE AN EVENT FROM THURSDAY (B)(6) 2018 BETWEEN 13:00 AND 15:30. THE DOCTOR SAW ALARMS, BUT THE ONE STATED BY THE NURSE "PA SYSTO BASSE" WOULD NOT HAVE SOUNDED. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED INCIDENT. ACCORDING TO THE CUSTOMER, THE PATIENT DIED. THE AGE, GENDER, HEIGHT, AND WEIGHT OF THE PATIENT WERE NOT AVAILABLE AT THE TIME THE REPORTING DECISION WAS DUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26821 MP70 INTELLIVUE PATIENT MONITOR PATIENT MONITOR DSI PHILIPS MEDICAL SYSTEMS M8007A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death