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

Model Number MERGE HEMODYNAMICS 9.40.1

Device Problems Failure to Transmit Record (1521); Device Issue (2379)

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

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

Replacement hardware, a coil cord (b)(4), was shipped to the customer on 24jan2017 (reference mdr #2183926-2017-00042, complaint-(b)(4)).The following day, 25jan2017, the customer called merge healthcare again reporting the same issue (this complaint).A replacement link (b)(4) was shipped to the customer on 25jan2017.The faulty hardware was returned to merge healthcare on 01feb2017 for evaluation.The customer stated that the data cable was loose and caused the hemo system to freeze.The results showed that no problems were found as the unit passed all testing.On and off for the next few weeks the customer and merge healthcare technical support continued to troubleshoot and attempt to resolve intermittent freezing issues.After a replacement coil cord and a replaced fuse, the issue appeared to have been resolved.In follow up communication with the customer by the quality compliance specialist on 21feb2017, it was confirmed that the problem had indeed been corrected and the hemo system is functioning correctly.In follow up communication with the customer by the quality compliance specialist on 21feb2017, it was confirmed that the problem had been corrected and the hemo system is functioning correctly.Device labeling, hemo-5303 v9.40 user manual, addresses such an occurrence in led behavior section which states, "5v led 4.5 to 5.5v - if it drops below or if there's a blown fuse on the hemo monitor pc's pci card, the led goes out; and "if low voltage is detected, the pdm goes to battery power and an audible alarm sounds." additionally in the equipment care section it states, "verify no external indications of problems (error leds, displayed error codes, failed drive alarms, etc.).".

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.On (b)(6) 2017, a customer reported to merge healthcare that problems were experienced with the hemo monitor freezing in the middle of a procedure after active monitoring and sedation had been initiated.Subsequently, the hemo monitor was rebooted twice and resulted in a loss of patient monitoring.The delay was ~10-15 minutes while the hemo system rebooted.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.However, the customer reported that the procedure was completed successfully once the hemo monitor was rebooted the second time.(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: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 6351935
• MDR Text Key: 68090973
• Report Number: 2183926-2017-00043
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 9.40.1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2014
• 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