BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 13095245 · Received December 28, 2021

    Report

    Report Number
    1218950-2021-11193
    Event Type
    Death
    Date Received
    December 28, 2021
    Date of Event
    December 13, 2021
    Report Date
    December 17, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    UDI-DI
    00884838048645
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER. A PHILIPS FIELD SERVICE ENGINEER WAS DISPATCHED FOR ONSITE SERVICE AND THE LOGS WERE RETRIEVED. A PHILIPS PRODUCT SUPPORT REPRESENTATIVE (PSR) REVIEWED THE PIC IX SERVICE LOGS, ALARM RECORDING AND PAGING LOGS FOR THIS EVENT. A PHILIPS CLINICAL SPECIALIST (CS) REVIEWED THE AUDIT LOG DATA. THE PATIENT MANAGEMENT LOGS INDICATED THAT THE PATIENT IN 216T WAS BEING MONITORED ON DEVICE 1080008. THE MONITOR HAD AN EQUIPMENT CHANGE AND THE BED WAS UPDATED IN SECTOR 0-1 FROM THE SURVEILLANCE. THE PIC IX SERVICE LOG SCREEN SHOWS BED TO BED OVERVIEW SESSIONS WERE OPENED FROM 1080008 TO SEVERAL BEDS INCLUDING 211F, 215T, 217T. THESE SESSIONS WERE FROM 20:47 TO 21:35. THIS SHOWS THAT CAREGROUP ALARM POP-UPS WERE ACTIVE. THERE WAS NO PRODUCT MALFUNCTION; THIS IS CONSIDERED A USER ISSUE. A SERIES OF ALARM RECORDING WERE GENERATED FROM BED 216T STARTING AT 21:00:32 THROUGH 21:34:58. THE PAGES WERE ALERTING TO SERIOUS TECHNICAL ALARMS, NO PULSE, NO SENSOR, ETC. THROUGHOUT THE PERIOD IN QUESTION. THE PIC IX SERVICE LOGS SHOW BED TO BED OVERVIEW SESSIONS WERE OPENED FROM 1080008 TO SEVERAL BEDS INCLUDING 211F, 215T, 217T. THESE SESSIONS WERE FROM 20:47 TO 21:35. THE AUDIT LOG AND ALARM RECORDING LOG SHOWS THAT ALARMS OCCURRED AT THE BEDSIDE MONITOR, THE INFORMATION CENTER, ALARM RECORDINGS WERE GENERATED AND WERE RESPONDED TO AT THE INFORMATION CENTER OR IN THE ROOM. THIS INFORMATION WAS PROVIDED TO THE CUSTOMER VIA LETTER. BASED ON PHILIPS¿ INVESTIGATION, THE PIC IX DEVICE IS OPERATING AS DESIGNED.

    Additional Manufacturer Narrative · 0

    (B)(6). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED: ON DECEMBER 13,.2021 AT 21:30, AN ASYSTOLE ALARM ON UNIT IMC BED 216F [LATER CLARIFIED AS 216T] WAS NOT INDICATED VIA BED-TO-BED MONITORING ACCORDING TO THE USER. AS A RESULT, THE ALARM WAS NOTICED TOO LATE, THE PATIENT HAD TO BE RESUSCITATED AND CONSEQUENTLY DIED.

    Description of Event or Problem · 0

    IT WAS REPORTED: ON (B)(6) 2021 AT 21:30, AN ASYSTOLE ALARM ON UNIT IMC BED 216F [LATER CLARIFIED AS 216T] WAS NOT INDICATED VIA BED-TO-BED MONITORING ACCORDING TO THE USER. AS A RESULT, THE ALARM WAS NOTICED TOO LATE, THE PATIENT HAD TO BE RESUSCITATED AND CONSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995188 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Death