BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDUCER X7-2T

    MDR report key: 14631108 · Received June 8, 2022

    Report

    Report Number
    14631108
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    May 17, 2022
    Report Date
    May 25, 2022
    Manufacturer
    PHILIPS ULTRASOUND INC.
    Product Code
    JOP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ANESTHESIOLOGIST WAS USING A TEE PROBE AND IE33 TEE MACHINE FOR A TAVR PROCEDURE. THE PROBE WAS IN THE PATIENT AND THE ANESTHESIOLOGIST STATED THAT HE WAS NOT GETTING AN IMAGE. THE ANESTHESIOLOGIST WAS ASKED IF HE WANTED A DIFFERENT PROBE OR IF HE WANTED A DIFFERENT TEE MACHINE. THE ANESTHESIOLOGIST STATED THAT HE WANTED A DIFFERENT TEE PROBE. THE ANESTHESIOLOGIST REMOVED THE EXISTING PROBE FROM THE PATIENT AND REPLACED IT WITH A DIFFERENT PROBE. THE REPLACEMENT PROBE PROVIDED AN IMAGE. THE ANESTHESIOLOGIST STATED THE IMAGE FROM THE REPLACEMENT PROBE WAS "VERY GRAINY". THE ANESTHESIOLOGIST WAS ASKED IF HE WANTED THE TEE MACHINE CHANGED. THE ANESTHESIOLOGIST CONFERRED WITH THE SURGEON AND DID NOT REQUEST ANY FURTHER EXCHANGES OF TEE EQUIPMENT. THE TEE PROBE THAT WAS NOT PROVIDING AN IMAGE WAS SENT TO STERILE PROCESSING FOR CLEANING AND TO BE SENT OUT FOR REPAIR. A LOANER TEE PROBE WAS REQUESTED.

    Description of Event or Problem · 0

    ANESTHESIOLOGIST WAS USING A TEE PROBE AND IE33 TEE MACHINE FOR A TAVR PROCEDURE. THE PROBE WAS IN THE PATIENT AND THE ANESTHESIOLOGIST STATED THAT HE WAS NOT GETTING AN IMAGE. THE ANESTHESIOLOGIST WAS ASKED IF HE WANTED A DIFFERENT PROBE OR IF HE WANTED A DIFFERENT TEE MACHINE. THE ANESTHESIOLOGIST STATED THAT HE WANTED A DIFFERENT TEE PROBE. THE ANESTHESIOLOGIST REMOVED THE EXISTING PROBE FROM THE PATIENT AND REPLACED IT WITH A DIFFERENT PROBE. THE REPLACEMENT PROBE PROVIDED AN IMAGE. THE ANESTHESIOLOGIST STATED THE IMAGE FROM THE REPLACEMENT PROBE WAS "VERY GRAINY". THE ANESTHESIOLOGIST WAS ASKED IF HE WANTED THE TEE MACHINE CHANGED. THE ANESTHESIOLOGIST CONFERRED WITH THE SURGEON AND DID NOT REQUEST ANY FURTHER EXCHANGES OF TEE EQUIPMENT. THE TEE PROBE THAT WAS NOT PROVIDING AN IMAGE WAS SENT TO STERILE PROCESSING FOR CLEANING AND TO BE SENT OUT FOR REPAIR. A LOANER TEE PROBE WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12307 TRANSDUCER X7-2T SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC JOP PHILIPS ULTRASOUND INC. X7-2T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown