BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPARQ ULTRASOUND SYSTEM

    MDR report key: 7076105 · Received December 1, 2017

    Report

    Report Number
    3019216-2017-00041
    Event Type
    Death
    Date Received
    December 1, 2017
    Date of Event
    November 17, 2017
    Report Date
    November 27, 2017
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    ITX
    PMA / PMN Number
    K123754
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE SITE¿S FIELD SERVICE ENGINEER WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. THE SPARQ UNIT PASSED ALL HARDWARE TESTS AND NO ABNORMALITIES WERE IDENTIFIED IN THE SYSTEM¿S LOGS. UPON ATTEMPTS TO FURTHER TROUBLESHOOT THE REPORTED ISSUE, THE CUSTOMER LOST CONFIDENCE IN THE SYSTEM AND REMOVED IT FROM SERVICE FOR CLINICAL USE. AS THIS CUSTOMER IS SERVICED BY A THIRD PARTY, IT IS UNLIKELY THIS SYSTEM WILL BE RETURNED FOR FURTHER EVALUATION. THIS THIRD PARTY IS REPLACING THE FAILED SYSTEM WITH ANOTHER ULTRASOUND DEVICE TO RESOLVE THE CUSTOMER¿S CONCERNS. NO ADDITIONAL INFORMATION COULD BE OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PATIENT HAD EXPIRED WHILE ATTEMPTING TO USE THEIR SPARQ ULTRASOUND SYSTEM. AS THE DOCTOR WAS PERFORMING CPR ON THE PATIENT, THE CUSTOMER COULD NOT TURN ON THE SYSTEM TO DIAGNOSE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854129 SPARQ ULTRASOUND SYSTEM TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX PHILIPS ULTRASOUND, INC 795090 US41210078

    Patients

    Seq Age Sex Outcome Treatment
    1 Death