BEUDAMED
    FDA Adverse Event Death Summary report: N

    S7-3T - 989605406771

    MDR report key: 7709994 · Received July 23, 2018

    Report

    Report Number
    3019216-2018-00039
    Event Type
    Death
    Date Received
    July 23, 2018
    Report Date
    July 18, 2018
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    ITX
    UDI-DI
    00884838061439
    PMA / PMN Number
    K043535
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED DEVICE CONFIRMED THE TEE TRANSDUCER HAD A SWOLLEN SHEATH, A WORN AND SCRATCHED HANDLE, RESIDUE ON THE CABLE JACKET, AND SCRATCHES ON THE TIP SHELL. THE SWOLLEN SHEATH WAS DETERMINED TO BE CAUSED BY CHEMICAL DAMAGE AND IS MITIGATED BY FOLLOWING DOCUMENTED INSTRUCTIONS FOR SAFE USE AND PROPER CLEANING. FURTHER INFORMATION FROM THE PHYSICIAN INVOLVED IN THE EVENT CONFIRMED THE TRANSDUCER WAS NOT THE CAUSE OF DEATH. THE PATIENT¿S DEATH WAS DUE TO VERY SEVERE VASCULAR MALFORMATIONS IN THE HEART, WHICH WERE INCOMPATIBLE WITH A SURVIVABLE PROGNOSIS. THE LACERATION IN THE ESOPHAGUS CAUSED BY THE TEE TRANSDUCER WAS REPAIRED BY A PEDIATRIC SURGEON.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER TESTED THE SUSPECT TRANSDUCER AT THE CUSTOMER SITE AND THE TRANSDUCER PASSED ALL FUNCTIONAL AND DIAGNOSTIC TESTING. THE TRANSDUCER RETURN IS ANTICIPATED AND A COMPLETE EVALUATION OF THE DEVICE WILL BE INCLUDED IN A FOLLOW-UP REPORT UPON ITS RETURN AND INVESTIGATION COMPLETION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN S7-3T MODEL TRANSDUCER PERFORATED A NEONATAL ESOPHAGUS WHILE UNDERGOING HEART SURGERY. DURING THE PROCEDURE THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553041 S7-3T - 989605406771 TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX PHILIPS ULTRASOUND, INC 989605406772 B210BC 00884838061439

    Patients

    Seq Age Sex Outcome Treatment
    1 Death