BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORESIGHT ELITE SENSOR, LARGE

    MDR report key: 15992533 · Received December 15, 2022

    Report

    Report Number
    2015691-2022-10045
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Date of Event
    December 9, 2022
    Report Date
    March 1, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    MUD
    PMA / PMN Number
    K143675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AT THE FACILITY AND NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN. THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED. A FSM WAS INVOLVED IN THIS EVENT. THE SUBMISSION NUMBER FOR THIS PRODUCT WILL BE SENT IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE FORESIGHT SENSORS WERE DISCARDED AND NOT AVAILABLE FOR EVALUATION. THEY WERE USED WITH THE FORESIGHT FSM AND NEITHER COULD BE RULED OUT AS A CONTRIBUTOR. REFER TO 2015691-2022-10054 FOR THE MDR FOR THE FORESIGHT FSM.

    Additional Manufacturer Narrative · 0

    REFER TO SUBMISSIONS 2015691-2022-10318, 2015691-2022-10054, 2015691-2022-10045 FOR THE SENSORS AND FORESIGHT MODULE INVOLVED IN THIS EVENT. H3 OTHER TEXT : DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE SOFTWARE LOGS WERE RETURNED FOR REVIEW. IT WAS NOTED THAT THE MONITOR INVOLVED IN THE EVENT WAS SET TO AN AVERAGING MODE OF FAST WHILE MONITORING AN ADULT PATIENT. THE AVERAGING MODE RECOMMENDED FOR AN ADULT PATIENT IS THE NORMAL SETTING. THERE WAS NOT SUFFICIENT EVIDENCE TO SUGGEST THAT THIS WAS A DEVICE RELATED MALFUNCTION OR A MANUFACTURING ISSUE. THE REPORTED ISSUE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE INACCURATE VALUES WHEN USING THE FORESIGHT LARGE SENSORS, DURING USE. THE SENSOR PLACEMENT WAS CEREBRAL. THE ANESTHESIOLOGIST STATED THAT THE VALUES THAT DISPLAYED DID NOT CORRELATE WITH THE CLINICAL SETTING. THE STO2 VALUES WERE WITHIN THE 50'S THROUGHOUT THE CASE. WHEN HE REPLACED THE SENSORS THEN THE VALUES INCREASE BY 20 POINTS. THE PATIENT WAS HEALTHY, PER THE ANESTHESIOLOGIST. THE PROCEDURE WAS TO REMOVE A SMALL TUMOR FROM THE LEFT VENTRICULAR WALL. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT. THERE WAS NO PATIENT HARM OR INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED AND NOT PROVIDED. THE LOT NUMBER OF THE SENSORS IS UNKNOWN. THE SENSORS WERE DISCARDED BY THE FACILITY AND ARE NOT AVAILABLE FOR RETURN. THE REP STATED THE FORESIGHT MODULE COULD NOT BE RULED OUT AS A CONTRIBUTOR. AN INITIAL MDR SUBMISSION WILL BE SENT FOR THE FSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437675 FORESIGHT ELITE SENSOR, LARGE FORESIGHT ELITE SENSOR, LARGE MUD EDWARDS LIFESCIENCES FSESL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown