BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPARQ ULTRASOUND SYSTEM

    MDR report key: 5064405 · Received September 9, 2015

    Report

    Report Number
    3019216-2015-00047
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Report Date
    September 4, 2015
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    ITX
    PMA / PMN Number
    K123754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED A 1 HOUR DELAY IN REBOOTING THE SPARQ ULTRASOUND SYSTEM DURING A PROCEDURE. DUE TO THE EXTENDED TIME THE PATIENT WAS SEDATED THE DECISION WAS MADE TO REPORT THIS EVENT. EVALUATION RESULTS OF THE SYSTEM ARE EXPECTED TO BE PROVIDED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    CUSTOMER WORDS: NOT SENSING START BUTTON, HAVE TO PRESS OVER AND OVER. TOOK 60 MINUTES TO BOOT UP IN THE MIDDLE OF A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595466 SPARQ ULTRASOUND SYSTEM TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX PHILIPS ULTRASOUND, INC 795090 US81510770

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown