BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE ALTA ADVANCED MONITORING PLATFORM

    MDR report key: 20949335 · Received December 17, 2024

    Report

    Report Number
    2015691-2024-09659
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 22, 2024
    Report Date
    February 7, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQK
    PMA / PMN Number
    K232294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. AN INVESTIGATION WILL BE COMPLETED TO CONSIDER ANY POTENTIAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT AND A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. 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.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING RECORDS WERE REVIEWED FOR THE SERIAL NUMBER INVOLVED AND THERE IS NO INDICATION OF A RELATED NONCONFORMANCE. ALL PROCESS PARAMETERS WERE MET AND INSPECTIONS PASSED SUCCESSFULLY. THE ISSUE WAS INVESTIGATED AND IT WAS DETERMINED THAT THE SYSTEM BEHAVED AS EXPECTED.

    Description of Event or Problem · 0

    AS REPORTED, DURING THIS TARGET MARKET RELEASE (TMR) AFTER BYPASSING THE PATIENT AND DURING ICU MONITORING WITH THIS HEMOSPHERE ALTA MONITOR (2024-29452-01), THERE WAS A VERY LARGE DISCREPANCY BETWEEN THE INTEGRATED CARDIAC OUTPUT (ICO) AND THE RIGHT VENTRICULAR CARDIAC OUTPUT (CORV), ~4 VS ~8. THESE VALUES WERE COMPARED WITH THE ECO IMAGES. THERE WAS NO ERROR MESSAGE DISPLAYED. THE PATIENT WAS NOT TREATED ACCORDING TO THE WRONG VALUES PROVIDED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THERE WILL BE NO PRODUCT RETURN AS THIS IS A TMR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720898 HEMOSPHERE ALTA ADVANCED MONITORING PLATFORM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK EDWARDS LIFESCIENCES ALTAALL1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown