BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEE FLEXIBLE PROBE

    MDR report key: 2994113 · Received February 18, 2013

    Report

    Report Number
    2994113
    Event Type
    Malfunction
    Date Received
    February 18, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 18, 2013
    Manufacturer
    PHILIPS
    Product Code
    BZT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT WAS IN THE EP LAB FOR A PLANNED TRANSESOPHAGEAL TRANSCARDIOGRAM (TEE)/CARDIOVERSION. PER THE INVESTIGATION/INTERVIEW WITH BIOENGINEERING, AND THE TEE TECH, THE PHILIPS TEE FLEXIBLE PROBE WAS PASSED AND THE PROCEDURE BEGAN. THE PHILIPS IE33 US MACHINE (THE BRAIN) GAVE AN ERROR MESSAGE AND FROZE. THE MACHINE WAS RESTARTED, HOWEVER THE PROBE COULD NOT BE AUTOCALIBRATED. ANOTHER PROBE WAS BROUGHT IN AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY INJURY/HARM TO THE PATIENT. PLEASE NOTE THE PROBE WAS A LOANER FROM MEDRAD MVS. BIOENGINEERING INSPECTED THE PROBE AND NOTED A SIGNIFICANT "DENT" AT THE PROXIMAL PORTION OF THE PROBE. IT IS UNCLEAR HOW THE DAMAGE OCCURRED. MEDRAD REP WAS CONTACTED. THE PROBE WAS RETURNED TO MEDRAD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70446 TEE FLEXIBLE PROBE PROBE, CATHETER, ESOPHAGEAL BZT PHILIPS T6H *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR