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

Device Problem Computer Operating System Problem (2898)

Patient Problem Insufficient Information (4580)

Event Date 09/12/2021

Event Type  malfunction  

Event Description

Merge hemo hemodynamic computer charting system stopped working three times during non-st-elevation myocardial infarction procedure, requiring hard reboot of computer.Cardiologist had to stop procedure with intra-coronary wires in place inside the patient while charting system reloaded.It team were not able to reproduce the problem.

• Brand Name: MERGE HEMO
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): MERGE HEALTHCARE SOLUTIONS INC.; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 12646829
• MDR Text Key: 276863442
• Report Number: 12646829
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32850 DA