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

Model Number MERGE HEMODYNAMICS 10.0.1

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Information (3190)

Event Date 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

On two (2) previous occasions, the customer reported similar problems (reference mdrs 2183926-2016-00621 and 2183926-2016-00622).Both times troubleshooting efforts were done through simulator use testing, and specific hardware replacement.On the third customer report, it was decided that the customer's entire system would be replaced.All new hardware for the hemo system was sent to the customer on 13jul2016 and 16jul2016.The faulty hardware has not yet been returned to merge for evaluation and testing.A supplemental report will be submitted when more information becomes available.(b)(4).

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) 2016, a customer reported to merge healthcare that the hemo hardware failed in the site's cath lab.Information obtained from the customer revealed that this site has only one (1) cath lab.The issue caused them to shut down for 2.5 days while troubleshooting efforts were completed.It was further revealed that patients were turned away.In one (1) instance, a patient who was admitted had to be discharged and sent to the customer's sister site to have their procedure completed.The patient was then readmitted to the customer's hospital once the procedure was completed.(b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted 14aug2016.As stated in the initial report, the customer's entire hemo system was replaced.At the time of the initial filing, the hardware evaluations had not yet been completed.Below are the evaluation results of the major component replacements: v2 4p masimo nibp 2.X (pdm - patient data module).The replacement hardware was shipped to the customer on (b)(6) 2016.The faulty unit was sent to the manufacturer for evaluation and received by merge healthcare on 29sep2016.The manufacturer's evaluation results showed that the customer's reported problem, pdm freezing, could not be duplicated.The unit was tested and no problems were found.V2 4p link assembly: the replacement hardware was shipped to the customer on (b)(6) 2016.The faulty unit was returned to merge healthcare on 16aug2016 for evaluation.The results showed that the customer's reported problem, hemo system freezing, could not be duplicated.The unit was tested and no problems were found.Hemo pc fru: the replacement hardware was shipped to the customer on (b)(6) 2016.The faulty unit was returned to merge healthcare on 27jul2016 for evaluation.The results showed that the customer's reported problem, network connection issues, could not be duplicated.However, both chassis fans were broken from their mounts and were subsequently remounted.The unit passed all diagnostics testing.A review of the hemo pc fru (dell t3600) owner's manual states that the operating temperature range is 10 °c to 35 °c (50 °f to 95 °f).It can be concluded that since the chassis fans were broken, the unit most likely overheated.

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 5874533
• MDR Text Key: 52076806
• Report Number: 2183926-2016-00685
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1