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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

Device Problems Failure to Power Up (1476); Power Problem (3010); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

The faulty ups was received by merge healthcare on 07nov2016 but has not yet been evaluated.For this reason, (b)(4) (conclusion not yet available-evaluation in progress) was used.When more information becomes available, a supplemental report will be submitted.

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 ups (uninterrupted power supply) was buzzing and the hemo application was not powering on in the site's (b)(6).If parts of the hemo system become energized, there is a potential for direct harm to the patient and/or user including electrical shock or burns.However, no reports were received of staff injury and information obtained indicated that the problem occurred when no patient was present.Additionally, the site has other cath labs for use.Reference complaint number (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 23nov2016.The faulty ups (uninterrupted power supply) was returned to merge healthcare on (b)(6) 2016 for evaluation and was internally documented on (b)(6) 2017.The evaluation results showed that the unit powered on but would become very noisy at times for unknown reasons.Subsequently, the unit was scrapped by merge healthcare.No information was found in the tripp lite owner's manual for smart and omnismart medical grade ups systems (smart1200xlhg, (b)(4)) that addresses a buzzing issue.For this reason, conclusions code 57 (labeling deficiency) was used.

• 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: 6126703
• MDR Text Key: 60907227
• Report Number: 2183926-2016-00802
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.3 PATCH 1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1