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

Model Number 9.30

Device Problem Computer Software Problem (1112)

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

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Merge hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.Customer reported an issue of several tabs on a case where locked even when there are no active workstations with the case checked out.This happened on the end study tab, the patient data study tab, labs tab and the study report tab.The hemo client supports concurrent user access.This requires that user interface (ui) elements be locked when one user is viewing / editing ui elements to prevent other users from making changes.Because data is written to the local database, an additional check is made to ensure that the locking data is the same on the server to ensure that all data has replicated to the server before freeing the lock.When a hemo client loses connection to the hemo server, any locks that this client had at the time will remain until that client is able to replicate its data to the server.This results in the inability for the user to be able to edit data for those tabs and chronological log entries.Due to the way that locking was implemented on 9.X systems, and the fact that hemo clients uses a local database, this can result in phantom locks.(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: 5437721
• MDR Text Key: 38227922
• Report Number: 2183926-2015-00362
• 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: 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: 9.30
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/17/2015
• Initial Date FDA Received: 02/16/2016
• 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
• Removal/Correction Number: 2183926-02/15/2016-048-C
• Patient Sequence Number: 1