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

Model Number	10.4.1
Medical Device Problem Code	Computer Operating System Problem (2898)
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 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.
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.H6 - investigation conclusion code: remove 44 added 4307.

• 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: 20297199
• Report Number: 2183926-2024-00002
• Device Sequence Number: 8866599
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• 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