BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE ADVANCED MONITORING PLATFORM, HEMOSPHERE FORESIGHT OXIMETER CABLE

    MDR report key: 20795057 · Received November 27, 2024

    Report

    Report Number
    2015691-2024-09019
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 4, 2024
    Report Date
    February 2, 2025
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DQK
    UDI-DI
    00690103208573
    PMA / PMN Number
    K223127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION D7 (SINGLE-USED DEVICE REPROCESSED AND REUSED ON A PATIENT?). THE REPORT OF INCORRECT VALUES WAS NOT CONFIRMED, SINCE NO DEFECT WAS FOUND AS THE ISSUE COULD NOT BE REPLICATED. HOWEVER, FROM VISUAL INSPECTION IT WAS DETECTED THAT THE CABLE OF THIS FORESIGHT MODULE WAS DAMAGED. BASED ON FURTHER ENGINEERING INVESTIGATION PERFORMED, PHYSICAL DAMAGE TO THE CABLE COULD POTENTIALLY BE ASSOCIATED TO HANDLING OF THE DEVICE BY THE END USER. ALL EVENTS WILL CONTINUE TO BE REVIEWED AND MONITORED.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RECEIVED BY OUR PRODUCT EVALUATION LABORATORY FOR A FULL EVALUATION. AS RECEIVED, FROM VISUAL INSPECTION IT WAS DETECTED THAT SOME PARTS OF THE CABLE OF THE FORESIGHT MODULE WERE DAMAGED. IT WAS CONNECTED TO A KNOWN GOOD HEMOSPHERE MONITOR AND THE MEASURES WERE PROPERLY DISPLAYED AND VALUES WERE AS EXPECTED. AFTER HOURS TAKING MEASURES NO DEFECTS WERE FOUND. THE MANUFACTURING RECORDS WERE REVIEWED FOR THE LOT INVOLVED AND THERE IS NO INDICATION OF A RELATED NONCONFORMANCE. ALL PROCESS PARAMETERS WERE MET AND INSPECTIONS PASSED SUCCESSFULLY. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Description of Event or Problem · 0

    AS REPORTED, DURING USE IN PATIENT, THIS HEMOSPHERE FORESIGHT MODULE (FSM) DID NOT MEASURE PROPERLY, THE VALUES DISPLAYED WERE NOT AS EXPECTED ACCORDING TO THE PHYSIOLOGICAL STATUS OF THE PATIENT. THE EXACT VALUES DISPLAYED COULD NOT BE CONFIRMED. THE ISSUE WAS ISOLATED TO THE FSM AFTER CONNECTING SAME SENSORS TO DIFFERENT MODULE AND CORRECT VALUES WERE DISPLAYED. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED AND UNABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832403 HEMOSPHERE ADVANCED MONITORING PLATFORM, HEMOSPHERE FORESIGHT OXIMETER CABLE COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK EDWARDS LIFESCIENCES LLC HEMFSM10 00690103208573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown