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

Model Number MERGE HEMO V.9.40

Device Problems Device Operational Issue (2914); Patient Data Problem (3197)

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

Event Date 10/14/2013

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.The customer contacted merge on 10/14/13 to report that the system is locked, and asked for help to unlock for data entry.The site was able to open the qsl by adding a 3.5gb max on sql (was at 4.5).However the cases were still locked.Merge cleared the locks in sql after backing up the phoenix database.The customer was contacted to let them know that the case could now be edited.The system is designed to allow users to lock a study or tab within the study to make changes.This ensures that two users can not make changes to the same study at the same time.However, in some instances the system will lock tabs within a study even when a second user does not have the study open on a different workstation.This "phantom" lock mimics the behavior described above except the lock is not caused by a second user but by the sql table.The lock might prevent users from calculating certain calculation that are required during the procedure since height and weight might be unavailable.(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: 5437914
• MDR Text Key: 38227927
• Report Number: 2183926-2015-00369
• 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

• 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: MERGE HEMO V.9.40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2013
• 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