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

Model Number	MERGE HEMODYNAMICS 10.0.3 PATCH 1
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Troubleshooting activities included the customer replacing the blown fuse with a spare that is provided with the computer.After replacement, it was reported that the voltage light would not turn on.After checking all the connections again, a loose cable was found and reconnected.It was confirmed that the voltage light issue was resolved.The customer confirmed to merge technical support on 03aug2018 that the issue had been resolved.Merge technical support reminded the customer that the hemo system should be turned off prior to unplugging any parts of the workstation to prevent blown fuses.For this reason, conclusion code 61 (unintended use error) was used.The potential impact to a patient has been reviewed and the severity level has been assessed as medium (non-serious injury).Device labeling, hemo-6373 v10 user manual, addresses the potential for such an occurrence as noted in the led behavior section, "5 v led 4.5 to 5.5 v: if it drops below or if there's a blown fuse on the hemo monitor pc's pci card, the led goes out." also found in the general equipment care section, it states, "inspect overall physical condition of the system components, peripherals, and interconnecting cables.Perform any corrective actions required." no further actions are anticipated at this time due to the issue being readily apparent to the user, troubleshooting information provided in the user manual, and the potential non-serious injury 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 "???" displayed on the hemo monitor and the pdm (patient data module) was not working caused from a blown fuse on the 12 v.It was further reported that a patient was present and was under sedation causing a delay in treatment to be greater than fifteen (15) minutes while the fuse was changed out and the hemo system rebooted.With merge hemo not capturing physiological data, there is a potential for incorrect treatment that could cause harm to the patient.The procedure was completed successfully once the fuse was replaced and the hemo application was rebooted.(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: 7831482
• Report Number: 2183926-2018-00082
• Device Sequence Number: 11069849
• Product Code: DQK
• UDI-Device Identifier: 00842000100010
• UDI-Public: 00842000100010
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 08/01/2018

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 10.0.3 PATCH 1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1