MAUDE Adverse Event Report: GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC MAC-LAB HEMODYNAMIC MONITORING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Catalog Number 2099200-002

Device Problems Device Displays Incorrect Message (2591); Computer Operating System Problem (2898)

Patient Problem No Information (3190)

Event Date 06/28/2018

Event Type  malfunction  

Event Description

Patient on the table in cath lab 3 for a procedure.When entering the patient into maclab, the system displayed that the amplifier was not available.Staff did troubleshooting by unplugging and plugging the amplifier back in and rebooting the system without success.Patient had to be moved to another room.

• Brand Name: MAC-LAB HEMODYNAMIC MONITORING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC; 9900 innovation drive; wauwatosa WI 53226
• MDR Report Key: 7762097
• MDR Text Key: 116448794
• Report Number: 7762097
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2099200-002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1