BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 10872118 · Received November 19, 2020

    Report

    Report Number
    1218950-2020-07040
    Event Type
    Death
    Date Received
    November 19, 2020
    Date of Event
    November 17, 2020
    Report Date
    November 17, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CLINICAL SPECIALIST (CS) WENT TO THE HOSPITAL SITE AND TOOK PICTURES OF THE PATIENT STRIPS AS WELL AS A PICTURE THE CS TITLED ¿RED ALERTS¿ THAT CONTAINED AN EXCERPT FROM THE AUDIT LOG FOR THE DATE AND TIME FRAME OF (B)(6), 2020 07:52:36 AM TO 08:21:55 AM. OUR PHILIPS PRODUCT SUPPORT ENGINEER (PSE) REVIEWED THE PICTURES. THE PSE REVIEWED THE PICTURES OF THE STRIP AND CONFIRMED THAT ***VENT FIB/TACH ALARMS WERE BEING GENERATED ON THE STRIPS. ***VENT FIB/TACH IS DISPLAYED ON THE STRIPS FOR (B)(6), 2020 AT 08:13 AM AND 08:14 AM. RED ALERTS PICTURE REVIEW: THE PSE REVIEWED THE PICTURE OF THE RED ALERTS FROM THE AUDIT LOG AND CONFIRMED SEEING ***VENT FIB/TACH ALARMS ON (B)(6), 2020 AT 08:13 AM, 08:14 AM, 08:15 AM, 08:16 AM, 08:17 AM, AND 08:21 AM. ON (B)(6), 2020 AT 08:20 AM AND 08:21 AM ***ASYSTOLE ALARM WAS GENERATED. IT ALSO SHOWS THAT ALARMS WERE BEING ACKNOWLEDGED. BASED ON OUR INVESTIGATION, PHILIPS DETERMINED THE MX40 ALARMED APPROPRIATELY AND OPERATED AS INTENDED. THE PSE'S EVALUATION WAS PROVIDED TO THE CUSTOMER. THE DEVICE REMAINS AT THE HOSPITAL SITE. THE INVESTIGATION CONCLUDED THE DEVICE DID NOT CAUSED OR CONTRIBUTE TO THE ADVERSE EVENT.

    Description of Event or Problem · 0

    THE HOSPITAL'S UNIT MANAGER REPORTED THAT A CODE BLUE EVENT OCCURRED THE MORNING OF (B)(6) 2020. THE PATIENT WAS IN A PACED RHYTHM THEN WENT INTO VENTRICULAR FIBRILLATION, AND WITH THE CHANGE IN RHYTHM, THE RED ALARM FOR VENTRICULAR FIBRILLATION DID NOT SOUND. THE PATIENT WAS RESUSCITATED THEN PRONOUNCED EXPIRED. THE MANAGER FURTHER STATED THAT A HOSPITAL UNIT MONITOR TECHNICIAN REVIEWED THE PATIENT ELECTROCARDIOGRAPH STRIPS (STRIPS) AND OBSERVED THAT A RED ALARM DID NOT SOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HOSPITAL'S UNIT MANAGER REPORTED THAT A CODE BLUE EVENT OCCURRED THE MORNING OF (B)(6) 2020. THE PATIENT WAS IN A PACED RHYTHM THEN WENT INTO VENTRICULAR FIBRILLATION, AND WITH THE CHANGE IN RHYTHM, THE RED ALARM FOR VENTRICULAR FIBRILLATION DID NOT SOUND. THE PATIENT WAS RESUSCITATED THEN PRONOUNCED EXPIRED. THE MANAGER FURTHER STATED THAT A HOSPITAL UNIT MONITOR TECHNICIAN REVIEWED THE PATIENT ELECTROCARDIOGRAPH STRIPS (STRIPS) AND OBSERVED THAT A RED ALARM DID NOT SOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337082 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death