BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMO

    MDR report key: 20297199 · Received September 24, 2024

    Report

    Report Number
    2183926-2024-00002
    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

    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 - INVESTIGATION CONCLUSION CODE: REMOVE 44 ADDED 4307.

    Description of Event or Problem · 0

    ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE REPORTED THAT DURING PROCEDURE ROOM PREPARATION ACTIVITIES, THE MERGE HEMO DEVICE'S KEYBOARD AND MOUSE WERE UNRESPONSIVE. MERGE HEMO HAS TOUCHSCREENS AS ANOTHER INTERFACE OPTION BESIDES A KEYBOARD AND MOUSE. HOWEVER, DUE TO THE INABILITY TO USE A KEYBOARD AND MOUSE WITH MERGE HEMO, PATIENT PROCEDURES WERE PERFORMED IN OTHER LABS ONSITE. MERGE HEALTHCARE TECHNICAL SUPPORT REMOTELY CONNECTED TO THE AFFECTED SYSTEM AND CONFIRMED THAT THE CLIENT PC'S USB PORTS WERE NOT COMMUNICATING. A REPLACEMENT PC WAS SHIPPED OVERNIGHT AND A RETURN MATERIAL AUTHORIZATION (RMA) WAS INITIATED FOR THE DEFECTIVE PC. PER POLICY, EQUIPMENT RETURNED FROM CLIENTS IS WIPED PRIOR TO PERFORMING SYSTEM DIAGNOSTICS TO PROTECT PATIENT INFORMATION. AFTER WIPING THE DRIVE AND REINSTALLING THE OPERATING SYSTEM, DIAGNOSTIC TESTS WERE PERFORMED AND THE USB PORTS WERE FOUND TO BE FUNCTIONAL. HENCE, THE ROOT CAUSE OF THIS ISSUE IS UNKNOWN. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: 300360000-2024-8014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263691 MERGE HEMO COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK MERGE HEALTHCARE 10.4.1 00842000100966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown