BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPARQ ULTRASOUND SYSTEM

    MDR report key: 11638467 · Received April 8, 2021

    Report

    Report Number
    3019216-2021-10044
    Event Type
    Death
    Date Received
    April 8, 2021
    Date of Event
    April 4, 2021
    Manufacturer
    PHILIPS ULTRASOUND
    Product Code
    IYN
    UDI-DI
    00884838097971
    PMA / PMN Number
    K091804
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ULTRASOUND SYSTEM WAS TESTED AT THE CUSTOMER SITE BY THE PHILIPS SERVICE ENGINEER AND NO PROBLEM WAS FOUND. A THOROUGH INVESTIGATION WAS PERFORMED TO IDENTIFY THE ROOT CAUSE OF THIS ISSUE, INCLUDING AN EVALUATION AND ANALYSIS OF THE LOGS FROM THE ULTRASOUND SYSTEM. THE SOFTWARE ENGINEERING TEAM WAS UNABLE TO REPRODUCE THE ISSUE DURING TESTING WHICH MADE IDENTIFYING THE ROOT CAUSE NOT POSSIBLE. THE SYSTEM IS STILL IN SERVICE WITH NO ADDITIONAL SIMILAR ISSUES REPORTED. THE CUSTOMER HAS ACKNOWLEDGED THE ULTRASOUND SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S OUTCOME.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THEIR SPARQ ULTRASOUND SYSTEM FAILED WHILE IN THE EMERGENCY ROOM. THE TOUCH PANEL BECAME UNRESPONSIVE IMMEDIATELY AFTER TURNING THE SYSTEM ON TO PERFORM A DIAGNOSIS. THE DOCTOR WAS UNABLE TO DIAGNOSE THE PATIENT UNTIL ANOTHER ULTRASOUND SYSTEM ARRIVED. THIS DELAYED THE DOCTOR¿S DIAGNOSIS FOR 30 MINUTES AND THE PATIENT ULTIMATELY EXPIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THEIR SPARQ ULTRASOUND SYSTEM FAILED WHILE IN THE EMERGENCY ROOM. THE TOUCH PANEL BECAME UNRESPONSIVE IMMEDIATELY AFTER TURNING THE SYSTEM ON TO PERFORM A DIAGNOSIS. THE DOCTOR WAS UNABLE TO DIAGNOSE THE PATIENT UNTIL ANOTHER ULTRASOUND SYSTEM ARRIVED. THIS DELAYED THE DOCTOR¿S DIAGNOSIS FOR 30 MINUTES AND THE PATIENT ULTIMATELY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532258 SPARQ ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND SPARQ DIAGNOSTIC ULTRASOUND SYSTEM 00884838097971

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death