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

Model Number MERGE HEMO V.9.4

Device Problems Application Program Problem (2880); Device Operational Issue (2914)

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

Event Date 04/30/2015

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be reportable as an mdr.

Event Description

Merge hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.Customer reported that a case was locked and they could not unlock for data entry.Merge support removed the locks that were on the study manually to allow the site to proceed.The locked tab could potentially impact the system's ability to complete certain calculations as the locked tab could include relevant information.(b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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 dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5437920
• MDR Text Key: 38218634
• Report Number: 2183926-2015-00365
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/15/2016

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 HEMO V.9.4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2183926-02/15/2016-048-C
• Patient Sequence Number: 1