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

Model Number	10.4.1
Medical Device Problem Codes	Computer Software Problem (1112); Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)
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 a user was unable to send completed cardiac catheterization patient reports to the emr post procedure.Merge healthcare has investigated the issue and determined that the inability to send reports to the emr was caused by a policy change within the customer's environment that affected file permissions.Without the appropriate file permissions, patient reports cannot be created and transferred to the emr.To resolve the issue, merge technical support restored the file permissions within the customer's environment.There have been no reports of patient injury or harm because of this issue.Reference: 300360000-2024-8015.
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 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 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 1112 and 3189, added 2017 investigation conclusion code: remove 51.This is the final report for 2183926-2024-00003.

• 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: 20297158
• Report Number: 2183926-2024-00003
• Device Sequence Number: 12710788
• 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