BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITI CVX ULTRASOUND SYSTEM

    MDR report key: 12831915 · Received November 17, 2021

    Report

    Report Number
    3019216-2021-10148
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 27, 2021
    Manufacturer
    PHILIPS ULTRASOUND
    Product Code
    IYN
    UDI-DI
    00884838101043
    PMA / PMN Number
    K212777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A THOROUGH INVESTIGATION WAS PERFORMED TO IDENTIFY THE ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, DUE TO INSUFFICIENT INFORMATION AND PART RETURNS, THE ENGINEERING TEAM WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THIS FAILURE. AN INTERNAL SCREW WAS TIGHTENED TO RESOLVE THE ISSUE AND NO ADDITIONAL SIMILAR PROBLEMS HAVE BEEN REPORTED POST REPAIR. ACTIONS ARE UNDERWAY TO ENSURE THE NECESSARY INFORMATION AND PARTS ARE RECEIVED TO FURTHER INVESTIGATE IF THIS ISSUE DOES RECUR.

    Additional Manufacturer Narrative · 0

    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 · 0

    THE CUSTOMER REPORTED AN INCIDENT WHERE THE SWIVEL MECHANISM OF THEIR AFFINITI CVX ULTRASOUND SYSTEM¿S CONTROL PANEL WOULD NOT LOCK INTO POSITION WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. A PHILIPS SERVICE ENGINEER TIGHTENED AN INTERNAL SCREW TO REPAIR THE SYSTEM. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE ULTRASOUND SYSTEM HAS BEEN RETURNED TO SERVICE WITH NO ADDITIONAL ISSUES REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN INCIDENT WHERE THE SWIVEL MECHANISM OF THEIR AFFINITI CVX ULTRASOUND SYSTEM¿S CONTROL PANEL WOULD NOT LOCK INTO POSITION WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. A PHILIPS SERVICE ENGINEER TIGHTENED AN INTERNAL SCREW TO REPAIR THE SYSTEM. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE ULTRASOUND SYSTEM HAS BEEN RETURNED TO SERVICE WITH NO ADDITIONAL ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725036 AFFINITI CVX ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND AFFINITI CVX DIAGNOSTIC ULTRASOUND SYSTEM (795190) 00884838101043

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown