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

Model Number	10.4.1
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); 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	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Merge healthcare has performed a root cause investigation of the heart rate issue reported by the user facility.The invesitgation determined that the merge hemo system is working in accordance with its design and is meeting specified performance parameters.Merge healthcare is working with the customer to resolve external factors in the use environment that are affecting performance of the system.
Event or Problem Description
On (b)(6) 2024, merge healthcare received a copy of a medsun report.A merge hemo customer reported: heart rate reporting as 4 beat per minute (bpm), actual heart rate 70 bpm.Merge healthcare has requested additional information from the customer for this event.There have been no reports of patient injury or harm because of this issue.
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 001.H2- indication of additional information.H6 - investigation conclusion code: 4323.This is the final report for 2183926-2024-00027.

• 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: 21021139
• Report Number: 2183926-2024-00027
• Device Sequence Number: 9087441
• 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
• Report Date (Section B): 12/26/2024

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: 11/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown