BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMO

    MDR report key: 20297230 · Received September 24, 2024

    Report

    Report Number
    2183926-2024-00006
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    August 26, 2024
    Report Date
    August 26, 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

    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 09/24/2024. MERGE HEALTHCARE IS UNABLE TO PERFORM A ROOT CAUSE INVESTIGATION FOR THIS ISSUE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, FULL DISCLOSURE DATA IS NOT SAVED INDEFINITELY AND IS NOT A MEANS OF PERMANENT STORAGE. DUE TO THE TIME ELAPSED BETWEEN THE PATIENT PROCEDURE AND THE MEDSUN REPORT, THE FULL DISCLOSURE FILES HAD BEEN PURGED FROM THE SYSTEM IN ACCORDANCE WITH ESTABLISHED PROTOCOLS. MERGE HEALTHCARE HAS BEEN INVESTIGATING OTHER ALLEGATIONS OF INACCURATE HEART RATE AND SPO2 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 OF THE SYSTEM. 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. INVESTIGATION FINDINGS (C): ADDED 3221. INVESTIGATION CONCLUSIONS (D): ADDED 4315.

    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. H6 - INVESTIGATION CONCLUSION CODE: 4323. THIS IS THE FINAL REPORT FOR 2183926-2024-00006.

    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 AN INACCURATE HEART RATE AND NO PULSE OXIMETRY VALUE BEING DISPLAYED. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED AN INACCURATE VALUE FOR HEART RATE AND NO PULSE OXIMETER/SPO2 VALUE DURING A DUAL CHAMBER PACEMAKER PLACEMENT PROCEDURE. 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
    2239156 MERGE HEMO COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK MERGE HEALTHCARE 10.4.1 00842000100966

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female