BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPARQ ULTRASOUND SYSTEM

    MDR report key: 8120964 · Received November 30, 2018

    Report

    Report Number
    3019216-2018-00054
    Event Type
    Death
    Date Received
    November 30, 2018
    Date of Event
    November 9, 2018
    Report Date
    November 9, 2018
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    ITX
    PMA / PMN Number
    K123754
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOUR INVOLVED SYSTEM BATTERIES WERE RETURNED TO PHILIPS FOR EVALUATION. EVALUATION OF THE BATTERIES FOUND ONE BATTERY WAS DEFECTIVE AND THE OTHER THREE WERE CHARGING NORMALLY. THE SPARQ SYSTEM DISPLAYS A BATTERY WARNING ICON WHEN A FAULTY BATTERY IS IDENTIFIED, BUT THE CUSTOMER COULD NOT VERIFY WHETHER THE WARNING MESSAGE APPEARED AT THE TIME OF SYSTEM USE. THE CUSTOMER DID ACKNOWLEDGE, HOWEVER, THAT THE DELAY IN SWAPPING THE SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE INFANT DEATH.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION TO DETERMINE THE CAUSE OF THIS ISSUE IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED TO PROVIDE ADDITIONAL EVALUATION DETAILS UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN INFANT HAD EXPIRED SHORTLY AFTER PERFORMING AN EMERGENCY C-SECTION PROCEDURE. THE CUSTOMER INTENDED TO USE A SPARQ ULTRASOUND SYSTEM TO DETECT THE FETAL HEART RATE WHILE STILL IN THE WOMB. THE SPARQ WOULD NOT START UP USING BATTERY POWER WHEN NEEDED, SO A DIFFERENT ULTRASOUND SYSTEM HAD TO BE BROUGHT IN WHICH DELAYED DETECTION OF A SLOW FETAL HEART RATE. THE EMERGENCY C-SECTION PROCEDURE WAS THEN PERFORMED AND THE INFANT EXPIRED SHORTLY THEREAFTER. ACCORDING TO THE REPORTED DETAILS, THE PATIENT HAD AN UNDISCLOSED PRE-EXISTING CONDITION WHICH MAY HAVE CONTRIBUTED TO THE EVENT. THE SYSTEM¿S BATTERIES HAVE BEEN REPLACED TO BRING THE SYSTEM BACK TO FULL FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959416 SPARQ ULTRASOUND SYSTEM TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX PHILIPS ULTRASOUND, INC 795090 US81511265

    Patients

    Seq Age Sex Outcome Treatment
    1 Death