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

Model Number MERGE HEMODYNAMICS 9.30

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

The customer requested a service authorization form for the damaged link assembly and coil cable, however further follow up with the customer found that the unit was repaired by the facility's biomedical department.Therefore, the unit was not returned to merge healthcare for evaluation and testing.Additional inquiry from the customer determined that after the unit was repaired, the issue was resolved.The customer confirmed that the unit works as expected.Per hemo-5303 merge hemo 9.40 user manual p.356 regarding general equipment care: inspect overall physical condition of the system components, peripherals, and interconnecting cables.Perform any corrective actions required.

Event Description

Merge hemodynamics monitors, 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.The customer reported to merge healthcare on october 5, 2017 that during a case while the patient was already sedated and being actively monitored, it was noted that the link assembly and the coil cable were damaged.Another unit was retrieved from a different lab and was exchanged with the damaged unit.The customer contact reported that there was a 10 minute interruption of patient monitoring while the units were being exchanged.No alternative monitoring equipment was used during the exchange.After the units were exchanged, it was reported that the hemo monitor pc was rebooted.The case was then completed successfully.There was no reported adverse event to the patient.However, with merge hemo not capturing physiological data, the device is not performing as intended, therefore has the potential to delay treatment that could cause harm to the patient.(b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: meg mucha ; 900 walnut ridge drive; hartland, WI 53029 ; 2623670700
• MDR Report Key: 6995518
• MDR Text Key: 91924897
• Report Number: 2183926-2017-00200
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/05/2017

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
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 9.30
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1