BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIIC IX UPGRADE FROM PIIC

    MDR report key: 8530116 · Received April 18, 2019

    Report

    Report Number
    1218950-2019-02951
    Event Type
    Death
    Date Received
    April 18, 2019
    Date of Event
    March 19, 2019
    Report Date
    March 20, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A PHILIPS RESPONSE CENTER ENGINEER (RCE) SPOKE TO A CUSTOMER BIOMEDICAL ENGINEER (BIOMED). THE RCE HAD THE BIOMED READMIT THE PATIENT INTO THE PIC IX, AND RUN ALARM STRIPS TO PROVIDE FOR REVIEW. THE RCE THEN REMOTELY ACCESSED THE CUSTOMER'S SYSTEM TO RETRIEVE LOGS AND A CLINICAL AUDIT. THE RCE RECEIVED THE ALARM STRIPS FROM THE BIOMED, AND REVIEWED WITH THE CLINICAL AUDIT AND ALARMS. THE CLINICAL AUDIT LOG SHOWED A PAUSE ALARM AT 13:32:08 FOLLOWED BY AN ASYSTOLE ALARM AT 13:32:28. THE ASYSTOLE ALARM WAS SEEN TO BE SILENCED AT 13:22:31. THE ASYSTOLE ALARM OCCURRED SEVERAL TIMES AFTER THIS, AND WAS SILENCED EACH TIME: THERE WAS NO PRODUCT MALFUNCTION; THE USER HAD SILENCED THE ALARM. THE RCE PROVIDED INFORMATION ON THE FINDINGS OF THE INVESTIGATION. THE DEVICE REMAINS IN USE AT THE CUSTOMER SITE, AND 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

    THE CUSTOMER REPORTED THAT THERE WAS A PATIENT DEATH ON (B)(6) 2019 AT BED K828A AT 13:30. THE CUSTOMER STATED THE ASYSTOLE EVENT SHOULD HAVE TRIGGERED A RED ALARM, HOWEVER, THE ALARM WAS YELLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319090 PIIC IX UPGRADE FROM PIIC CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866117

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death