BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 10992303 · Received December 11, 2020

    Report

    Report Number
    1218950-2020-07707
    Event Type
    Malfunction
    Date Received
    December 11, 2020
    Date of Event
    November 19, 2020
    Report Date
    November 20, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR ONSITE SUPPORT. LOGS WERE RETRIEVED AND REVIEWED BY PHILIPS CLINICAL SUPPORT PERSONNEL. THE INVESTIGATION DETERMINED THAT AN ASYSTOLE ALARM WAS GENERATED AT 11:10:27. THE ALARM WAS SILENCED AT 11:11:02 FROM THE SURVEILLANCE CENTER. AT 11:15:24 A STRIP WAS ANNOTATED FROM 11:13:01 CODE BLUE CALLED. THE PIC IX IS DESIGNED FOR ALL ALARMS TO FILTER THROUGH THE PIC IX PRIOR TO GOING TO THE PAGING SYSTEM. IT IS NOT POSSIBLE TO GET A PAGE FOR AN ALARM UNLESS IT FIRST OCCURS AT THE PIC IX. THERE WAS NO PRODUCT MALFUNCTION; THIS IS CONSIDERED A USER ISSUE. THE PIC IX WAS OPERATING AS DESIGNED. SMALL QRS COMPLEXES WERE NOT BEING COUNTED AS THEY MEASURED <1/2 SIZE OF 1 MV BAR. THE QRS COMPLEXES WERE NOT MEASURED AS A RHYTHM AND THE RESULT WAS AN ASYSTOLE ALARM. THE ASYSTOLE ALARM WAS SILENCED FROM THE SURVEILLANCE CENTER. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    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 ON (B)(6) 2020 AT APPROXIMATELY 11:00, THE MONITOR ALARMED FOR AN ASYSTOLE, THOUGH THERE WAS A RHYTHM PRESENT WITH SMALL QRS COMPLEXES. THE PATIENT HAD A CARDIAC ARREST AND EXPIRED. THE FLOOR NURSE RECEIVED AN ASYSTOLE ALARM VIA PAGE BUT TELEMETRY TECHS DID NOT RECEIVE ASYSTOLE ALARM ON SURVEILLANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459357 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death