BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMO

    MDR report key: 20300207 · Received September 25, 2024

    Report

    Report Number
    2183926-2024-00012
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    August 29, 2024
    Report Date
    August 29, 2024
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    DQK
    UDI-DI
    00842000100966
    PMA / PMN Number
    K152864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION INTO THE REPORTED ISSUE IS ONGOING. AT THIS TIME, MERGE HEALTHCARE HAS NOT IDENTIFIED A DEFECT OR MALFUNCTION WITH MERGE HEMO THAT CAUSED OR CONTRIBUTED TO NO HEART RATE BEING DISPLAYED. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    UPDATED THE FOLLOWING FIELDS: MEDSUN # (B)(4) IN H10, 510K NUMBER K152864 IN G4, TYPE OF REPORT FOLLOW UP 001 IN G6.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTED TO THE FDA IN ACCORD WITH APPLICABLE REGULATIONS AND AS INDICATED BY MERGE HEALTHCARE IN THE INITIAL REPORT SUBMITTED 09/25/2024. MERGE HEALTHCARE HAS PERFORMED A ROOT CAUSE INVESTIGATION OF THE HEART RATE ISSUE REPORTED BY THE USER FACILITY. THE INVESTIGATION DETERMINED THAT THE MERGE HEMO SYSTEM IS WORKING IN ACCORDANCE WITH ITS DESIGN AND IS MEETING SPECIFIED PERFORMANCE PARAMETERS. MERGE HEALTHCARE IS WORKING WITH THE CUSTOMER TO RESOLVE EXTERNAL FACTORS IN THE USE ENVIRONMENT THAT ARE AFFECTING PERFORMANCE. REVISED INFORMATION CONTAINED IN THIS SUPPLEMENTAL REPORT INCLUDES THE FOLLOWING: G6 - INDICATION THAT THIS IS FOLLOW-UP REPORT 002. H1 - INDICATION OF MALFUNCTION AS REPORTABLE EVENT. H2 - INDICATION OF ADDITIONAL INFORMATION. H6 - EVALUATION CODES: MEDICAL DEVICE PROBLEM CODE (A): REMOVE 1112; ADDED 2017. COMPONENT CODE (G): REMOVE 4707 AND 4709; ADDED 510. INVESTIGATION FINDINGS (C): ADDED 213. INVESTIGATION CONCLUSIONS (D): ADDED 4310 AND 4323.

    Additional Manufacturer Narrative · 0

    MERGE HEALTHCARE HAS PERFORMED A COMPREHENSIVE INVESTIGATION AND RISK TO HEALTH ANALYSIS OF THE REPORTED ISSUE. THE INVESTIGATION DETERMINED THAT NO MALFUNCTION OF THE DEVICE OCCURRED, AND THE HEALTH HAZARD EVALUATION CONCLUDED THAT THE EVENT IS UNLIKELY TO RESULT IN ANY ADVERSE HEALTH CONSEQUENCES. NO PATIENT HARM HAS OCCURRED AS A RESULT OF THE EVENTS REPORTED BY THE CUSTOMER FACILITY. MERGE HEALTHCARE WILL CONTINUE TO FOLLOW UP WITH FACILITY STAFF TO PREVENT FUTURE OCCURRENCES OF THE ISSUE. REVISED INFORMATIONCONTAINED IN THIS SUPPLEMENTAL REPORT INCLUDE THE FOLLOWING: G6 - INDICATION THAT THIS IS FOLLOW-UP REPORT 003. H2-INDICATION OF ADDITIONAL INFORMATION. THIS IS THE FINAL REPORT FOR 2183926-2024-00012.

    Description of Event or Problem · 0

    ON 08/29/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED NO VALUE FOR HEART RATE DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. USER WAS ABLE TO GET AN ACCURATE HEART RATE AFTER CHANGING LEADS MULTIPLE TIMES. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2248773 MERGE HEMO COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK MERGE HEALTHCARE 10.4.1 00842000100966

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male