BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMO

    MDR report key: 20300213 · Received September 25, 2024

    Report

    Report Number
    2183926-2024-00013
    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
    NURSE
    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

    MERGE HEALTHCARE HAS PERFORMED A COMPREHENSIVE INVESTIGATION AND RISK TO HEALTH ANALYSIS OF THE REPORTED ISSUE. 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 INFORMATION CONTAINED IN THIS SUPPLEMENTAL REPORT INCLUDE THE FOLLOWING: G6 - INDICATION THAT THIS IS FOLLOW-UP REPORT 002 H2-INDICATION OF ADDITIONAL INFORMATION H6 - MEDICAL DEVICE PROBLEM CODE:REMOVE 2880 INVESTIGATION CONCLUSION CODE: REMOVE 58 ADDED 44. THIS IS THE FINAL REPORT FOR 2183926-2024-00013.

    Description of Event or Problem · 0

    ON 08/29/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER REPORTED THAT THE CLIENT/DOCUMENTATION SIDE OF THE DEVICE HAD A SPINNING WHEEL ON THE SCREEN DURING A ST SEGMENT ELEVATION MYOCARDIAL INFARCTION PROCEDURE. MERGE HEMO CONTINUED TO DISPLAY AND UPDATE THE PATIENT'S VITAL SIGNS. THE USER, A REGISTERED NURSE, WAITED APPROXIMATELY FOUR MINUTES AND THEN REBOOTED THE CLIENT/DOCUMENTATION PC SO THAT DOCUMENTING THE PROCEDURE COULD CONTINUE. MERGE HEALTHCARE HAS INVESTIGATED THE ISSUE, BASED ON WHAT THE CUSTOMER PROVIDED IN THE MEDSUN REPORT. IT APPEARS THAT THE SPINNING WHEEL ISSUE PROBABLY OCCURRED DUE TO A SOFTWARE DEFECT. MERGE HEALTHCARE IS WORKING WITH THE CUSTOMER TO PROVIDE A SOFTWARE UPDATE. 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
    1198777 MERGE HEMO COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK MERGE HEALTHCARE 10.4.1 00842000100966

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male