MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MLCL CLIENT SOFTWARE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ALTIX

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 06/02/2022

Event Type  malfunction  

Event Description

Issue has occurred three times in 2022: over the last few months.During thermodilution cardiac output (tdco) procedures, the hemodynamic recording program, which is run off ge mac-lab altix bt21 units, will become non-responsive and require a hard restart of either the entire system or the program.During this time, monitoring of the patient is lost and needs to be transferred to a separate monitoring system while the lab waits for the mac-lab system to reboot.Additionally, previously collected tdco data that was open when program froze is lost, meaning that the lab must perform the procedure again.In all three events, tdco measurements were being taken in groups of three injections which are averaged to produce the final measurement.In all three events, the program became non-responsive at the conclusion of the third injection, meaning that all three injections needed to be performed again after the system rebooted.In the first two events, the mac-lab system pc had to undergo a hard restart to correct the issue.During the most recent event, the cath lab technician was able to avoid hard restarting the pc and was able to shut down and restart the mac-lab software by using windows task manager.While this shortened the amount of time that the patient was off mac-lab monitoring, the measurement data from the previous two injections was still lost and the procedure had to be performed again.This issue has occurred on two separate machines.After each restart of the program or pc, the system works without issue for the rest of the case.We have been unable to recreate the failure in a controlled setting with a patient simulator, and windows system and application logs do not seem to record the error that led to the program becoming non-responsive.Manufacturer response for computer, diagnostic, programmable, mlcl client software (per site reporter).Manufacturer's investigation into this issue is ongoing.Manufacturer response for computer, diagnostic, programmable, mlcl client software (per site reporter).Manufacturer's investigation into this issue is ongoing.

• Brand Name: MLCL CLIENT SOFTWARE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 3000 n grandview blvd; waukesha WI 53188
• MDR Report Key: 15224521
• MDR Text Key: 297905644
• Report Number: 15224521
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALTIX
• Device Catalogue Number: 5889605
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA
• Patient Sex: Male