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

Model Number MERGE HEMO V. 9.20

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operational Issue (2914)

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

Event Date 07/24/2013

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. On (b)(6) 2013, it was reported that the hemomonitor. Exe has stopped working - error message in cathlab 2. A trap was set up to log the errors. A debug patch was applied on (b)(6) 2015. This error impacts the physician's ability to continue vitals monitoring during cath procedures. (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: 5437936
• Report Number: 2183926-2015-00385
• 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

• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: MERGE HEMO V. 9.20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/24/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

• Removal/Correction Number: 2183926-02/15/2016-031-C