BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CX50 ULTRASOUND SYSTEM

    MDR report key: 19023182 · Received April 2, 2024

    Report

    Report Number
    3019216-2024-00048
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 14, 2024
    Report Date
    June 21, 2024
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838025295
    PMA / PMN Number
    K123754
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A THOROUGH INVESTIGATION WITH A DEVICE ANALYSIS WAS PERFORMED AND THE CABLE DAMAGE WAS CONFIRMED. THE EXPOSED LIVE WIRE WOULD HAVE PRODUCED AN ELECTRIC SHOCK TO THE USER OR ANY METAL SURFACES OF THE CART IF IT CAME INTO CONTACT. THERE WAS A PUNCTURE TO THE CABLE IN WHICH THE INSULATION ON THE OUTER SHEATH WAS STRIPPED OFF AND THE LIVE WIRE WAS EXPOSED. IT WAS NOT POSSIBLE TO PROVIDE AN ACCURATE CAUSE OF THE DAMAGE.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL INFORMATION WAS RECEIVED 30APR2024 REPORTING THE USER, WHO WAS SHOCKED, HAD NO SYMPTOMS OR CONSEQUENCES AND DID NOT SEEK MEDICAL ATTENTION. THIS EVENT DOES NOT MEET THE CRITERIA FOR A SERIOUS INJURY. H11: CORRECTIONS TO INITIAL REPORT: ADVERSE EVENT/PRODUCT PROBLEM: PRODUCT PROBLEM TYPE OF REPORTED COMPLAINT: PRODUCT PROBLEM PATIENT OUTCOME CODE GRID: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS HEALTH IMPACT GRID: MINOR INJURY/ILLNESS/IMPAIRMENT

    Description of Event or Problem · 0

    A USER FACILITY REPORT BFARM 08301/24 WAS RECEIVED THAT REPORTED A SERIOUS INJURY ON 14MAR2024 IN WHICH A DOCTOR'S ASSISTANT PICKED UP THE CX50 ULTRASOUND SYSTEM FOR A PATIENT EXAM AND TOUCHED THE UNINSULATED SECTION OF THE POWER CORD. THE USER RECEIVED AN ELECTRICAL SHOCK TO THE RIGHT HAND. IT WAS UNSPECIFIED IF MEDICAL INTERVENTION WAS REQUIRED AND THE EXTENT OF THE PHYSICAL INJURY FROM THE SHOCK IS CURRENTLY UNKNOWN. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666049 CX50 ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 00884838025295

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other