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

Model Number 9.30

Device Problems Application Program Problem (2880); Device Operates Differently Than Expected (2913)

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

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be a reportable event.

Event Description

Merge hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.A customer reported (case (b)(4)) that a case for a patient done on (b)(6) shows a patient name from (b)(6).Patient a study was created on (b)(6) 2015, report signed and approved on (b)(6) 2015.Patient b study was created on (b)(6) 2015, report signed and approved on (b)(6) 2015.Patient b profile wasn't created until (b)(6) 2015.Patient a mrn was updated to be associated with patient b name.Investigation determined patient a's study and report were saved with patient a's mrn in the emr and the same occurred with patient b's.This issue was confirmed to be due to manual updates by a user.

• Brand Name: MERGE HEMO
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5437594
• MDR Text Key: 38227799
• Report Number: 2183926-2015-00150
• 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
• Type of Report: Initial
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9.30
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2013
• 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