MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMODYNAMICS; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number	MERGE HEMODYNAMICS 10.1
Medical Device Problem Codes	Communication or Transmission Problem (2896); Noise, Audible (3273)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During troubleshooting efforts with the customer, merge healthcare technical support instructed the user how to reset the pdm (patient data module) as well as the hemo monitor and client pc in the proper boot up sequence.The customer confirmed that the issue was resolved.The potential impact to the patient has been reviewed and the risk level has been assessed as medium (non-serious injury).Device labeling, hemo-6373 v10 user manual, addresses the potential for such an occurrence in the troubleshooting section by statements such as, "problem - ecg error messages, resolution - several possible messages may appear on the hemo monitor if the system is unable to achieve reliable vitals readings.For example, if a lead is not properly attached to the patient or to the pdm, rather than offer a weak or inaccurate reading, the hemo monitor will indicate the affected lead with a lead off or not available message in white text.Check the lead's connection to the pdm and to the patient.Check for kinks or damage".No further actions are anticipated at this time due to the issue being readily apparent to the user and the non-serious impact to a patient.(b)(4).
Event or Problem Description
Merge hemodynamics displays, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure.The system comprises the patient data module and the merge hemodynamics hemo monitor pc.The two units are connected via a serial interface.All vital parameters and evaluations are registered and calculated in the patient data module.This data is then transmitted to the merge hemodynamics hemo monitor pc via the serial interface.All data can be shown and monitored on the merge hemodynamics hemo monitor pc.On (b)(6) 2018, a customer reported to merge healthcare that the pdm (patient data module) started alarming and no patient vitals were displayed in the middle of a procedure.Subsequently, the patient was moved to another lab.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.However, it was reported that the procedure was completed successfully once the patient was moved to a known working lab.Reference complaint (b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Common Device Name: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 7594518
• Report Number: 2183926-2018-00050
• Device Sequence Number: 1698300
• Product Code: DQK
• UDI-Device Identifier: 00842000100034
• UDI-Public: (01)00842000100034(10)10105380(11)170918
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K082421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2018

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: MERGE HEMODYNAMICS 10.1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1