BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X72T TRANSESOPHAGEAL TRANSDUCER

    MDR report key: 4169256 · Received September 17, 2014

    Report

    Report Number
    4169256
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 17, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    JOP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED WITH MITRAL VALVE DISEASE FOR CORONARY ARTERY BYPASS GRAFT AND MITRAL VALVE REPLACEMENT. A POST-OP 2-D TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED IN SURGERY. DURING THE PROCEDURE, THE TEE PROBE LOST FULL MOVEMENT FUNCTION. THE PROBE WOULD NOT ROTATE TO SCAN DIFFERENT PLANES. THE CARDIOLOGIST WAS ABLE TO OBTAIN LIMITED VIEWS. THE PATIENT WAS NOT HARMED BY THE EQUIPMENT MALFUNCTION. THE TEE INTRAOPERATIVE WAS PERFORMED TO ASSESS THE PROSTHETIC MITRAL VALVE FUNCTION. THE PROSTHETIC MITRAL VALVE IS WELL-SEATED. THE PATIENT HAD A PERMANENT PACEMAKER PLACED APPROXIMATELY 6 DAYS LATER AND REMAINS HOSPITALIZED FOR RECOVERY. THERE HAVE BEEN NO COMPLICATIONS. BIOTECH DID NON-DESTRUCTIVE TESTING ON THE ULTRASOUND UNIT, WHICH IS FUNCTIONING NORMALLY AND WAS RETURNED TO SERVICE. THE TEE PROBE REMAINS IN SEQUESTER AT THE HOSPITAL. THE PROBE SHOWS NO VISIBLE DAMAGE.======================MANUFACTURER RESPONSE FOR TRANSESOPHAGEAL ECHOCARDIOGRAM PROBE, PHILIPS TRANSESOPHAGEAL PROBE (PER SITE REPORTER).======================MANUFACTURER WILL DO NON-DESTRUCTIVE TESTING TO EVALUATE THE TEE PROBE AS SOON AS A MEMO OF UNDERSTANDING IS SIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576613 X72T TRANSESOPHAGEAL TRANSDUCER TRANSESOPHAGEAL ECHOCARDIOGRAM PROBE JOP PHILIPS MEDICAL SYSTEMS X72T *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR NO OTHER THERAPIES