BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ 7C ULTRASOUND CHINA LOCAL

    MDR report key: 17051745 · Received June 2, 2023

    Report

    Report Number
    3019216-2023-00075
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 16, 2023
    Report Date
    June 4, 2026
    Manufacturer
    PHILIPS ULTRASOUND (SHANGHAI) CO., LTD
    Product Code
    IYN
    UDI-DI
    00884838108394
    PMA / PMN Number
    K181485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: PHILIPS HAS STARTED AN INVESTIGATION TO DETERMINE THE CAUSE. H11: EVALUATION METHOD, RESULTS, CONCLUSION CODES UPDATED TO REFLECT PENDING THE INVESTIGATION. INITIAL IT WAS REPORTED THE ENGINEER REMOVED AC POWER AND BATTERY POWER, WAITED SOME TIME AND THEN REBOOTED THE SYSTEM TO RETURN TO FULL FUNCTIONALITY. THIS INFORMATION WAS INADVERTENTLY REPORTED. THE ENGINEER INSTEAD TIGHTENED THE ARM.

    Additional Manufacturer Narrative · 0

    510K NUMBER NOT PROVIDED ON INITIAL REPORT. K181485.

    Additional Manufacturer Narrative · 0

    H10: A THOROUGH INVESTIGATION WAS PERFORMED AND IT WAS DETERMINED THAT THE ROOT CAUSE WAS RELATED TO MECHANICAL ISSUE DUE TO A SCREW BECOMING UNTIGHTENED. ENHANCEMENTS TO THE DESIGN ARE CURRENTLY UNDER CONSIDERATION.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 7C ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE SERVICE ENGINEER EVALUATED THE SYSTEM AND FOUND THE CONTROL PANEL SWIVEL WAS NOT LOCKING. THE ENGINEER REMOVED AC POWER AND BATTERY POWER, WAITED SOME TIME AND THEN REBOOTED THE SYSTEM TO RETURN TO FULL FUNCTIONALITY.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 7C ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE SERVICE ENGINEER EVALUATED THE SYSTEM AND FOUND THE CONTROL PANEL SWIVEL WAS NOT LOCKING. THE ENGINEER REMOVED AC POWER AND BATTERY POWER, WAITED SOME TIME AND THEN REBOOTED THE SYSTEM TO RETURN TO FULL FUNCTIONALITY.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 7C ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE SERVICE ENGINEER EVALUATED THE SYSTEM AND FOUND THE CONTROL PANEL SWIVEL WAS NOT LOCKING. THE ENGINEER REMOVED AC POWER AND BATTERY POWER, WAITED SOME TIME AND THEN REBOOTED THE SYSTEM TO RETURN TO FULL FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371216 EPIQ 7C ULTRASOUND CHINA LOCAL SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND (SHANGHAI) CO., LTD 00884838108394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown