MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMO; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	10.4.1
Medical Device Problem Codes	Computer Software Problem (1112); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/26/2024, merge healthcare received a copy of a medsun report.A merge hemo customer reported that the client/documentation side of the device shut down during a st segment elevation myocardial infarction procedure.The physician was able to proceed with the procedure and care for the patient because merge hemo continued to display and update the patient's vital signs throughout the procedure.The customer relogged into the merge hemo client so that documenting could continue.Merge healthcare has investigated the issue and determined that this issue 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).
Additional Manufacturer Narrative
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
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.This is the final report for 2183926-2024-00004.

• Brand Name: MERGE HEMO
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer Contact: nadia marchant ; 900 walnut ridge dr; hartland, WI 53029 ; 8446372848
• MDR Report Key: 20297252
• Report Number: 2183926-2024-00004
• Device Sequence Number: 8883869
• Product Code: DQK
• UDI-Device Identifier: 00842000100966
• UDI-Public: (01)00842000100966(10)10.4.1(11)211214
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K152864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10.4.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/13/2024; 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown