BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S7-3T - 989605406771

    MDR report key: 10345311 · Received July 30, 2020

    Report

    Report Number
    3019216-2020-00048
    Event Type
    Injury
    Date Received
    July 30, 2020
    Date of Event
    June 17, 2020
    Report Date
    July 2, 2020
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    ITX
    UDI-DI
    00884838061439
    PMA / PMN Number
    K043535
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED TRANSDUCER WAS EVALUATED AND AFTER THOROUGH INSPECTION AND TESTING, THE TRANSDUCER PASSED ALL TESTS AND WAS CONFIRMED TO BE FUNCTIONING AS DESIGNED. THE RESULTS OF OUR CLINICAL INVESTIGATION SUGGEST THAT THE REPORTED INJURIES ARE MOST LIKELY DEVICE RELATED PRESSURE ULCERS (DRPU) CAUSED BY PROLONGED PRESSURE FROM THE TEE TRANSDUCER IN CONTACT WITH THE LIP AND/OR SKIN. SURGERY ASSOCIATED WITH TEE TRANSDUCERS THAT LASTS LONGER THAN TWO HOURS HAS BEEN ASSOCIATED WITH PRESSURE INJURIES (PI). THIS COULD ULTIMATELY LEAD TO DEVICE RELATED PRESSURE ULCERS ESPECIALLY WITH PATIENTS IN PEDIATRIC INTENSIVE CARE UNITS. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE TRANSDUCER WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS RETURN AND INVESTIGATION COMPLETION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WITH THEIR S7-3T TRANSESOPHAGEAL TRANSDUCER DURING A PEDIATRIC SURGICAL PROCEDURE FOR CONGENITAL HEART DISEASE. THE PATIENT¿S UPPER LIP PRESENTED AN APPARENT SMALL BURN WHERE THE TRANSDUCER WAS POSITIONED. THIS ISSUE DID NOT IMPACT THE OUTCOME OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808998 S7-3T - 989605406771 TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX PHILIPS ULTRASOUND, INC 989605406772 B2HWWZ 00884838061439

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention