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

Model Number MERGE HEMODYNAMICS 9.40.3

Device Problems Computer Software Problem (1112); Device Issue (2379)

Patient Problems Cardiac Arrest (1762); Respiratory Failure (2484)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

Remote diagnostic testing was performed on the customer's hemo software.It was found that the pdm firmware was version 2.52.02 and the site was using nelcor, so the firmware was upgraded to 2.52.04.The customer tested the software and stated that the pleth waveform and a valid reading were displayed and verified that the software functioned correctly.The customer confirmed that the site's other lab already had the correct version of firmware installed.The system was returned to service at the customer site.

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 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 hemodynamics hemo monitor pc via the serial interface.All data can be shown and monitored on the hemodynamics hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that the nibp and spo2 were not functioning properly during a case that resulted in the patient coding and respiratory failure.The o2 level remained at 100%.Information obtained from the customer revealed that the involved patient was considered high risk and had been previously diagnosed with several co-morbidity diseases.However, the patient presented stable vital signs so sedation was administered.Shortly thereafter, the patient coded and required intubation.The patient was administered medication and was revived.Due to the inability to gain vascular access, the procedure was stopped.A less-invasive procedure will be scheduled in the future.(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; harland, WI 53029 ; 2629123570
• MDR Report Key: 5536909
• MDR Text Key: 41512327
• Report Number: 2183926-2016-00516
• 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: Other
• Type of Report: Initial
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 9.40.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2015
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR
• Patient Weight: 73