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

Model Number 9.4

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 02/07/2014

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.Merge healthcare received reports of hemomonitor application crashes with the following error - "hemomonitor.Exe has stopped working unexpectedly" being displayed on the desktop.This error does not restart the computer, since no keyboard and mouse are available the customers have had to restart via the front panel power button.This issue did not result in a serious injury to the patient.This error may impact the physician's ability to continue vitals monitoring during cath procedures.(b)(4).

• Brand Name: MERGE HEMO
• 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 rd; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5437751
• MDR Text Key: 38221710
• Report Number: 2183926-2015-00405
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/31/2016

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: Health Professional
• Device Model Number: 9.4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2014
• 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: Reuse
• Removal/Correction Number: 2183926-02/15/2016-031-C
• Patient Sequence Number: 1