MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MAC; ELECTROCARDIOGRAPH

Model Number VU360

Device Problems Application Program Problem (2880); Data Problem (3196)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2021

Event Type  malfunction  

Event Description

The macvu360 ekg machines have documented not to keep time accurately and it is posing a problem with time documentation such as stemis (st-elevation myocardial infarction) where the ekg to balloon time is measured.We currently have 46 machines and ge has been contacted over the last couple of months to be notified and to correct the situation by our clinical engineering (ce) team.The discrepancy in the time reported by the ekg machine and current time is currently being addressed by ce team rounding on the entire hospital to manually address the time issues.Couple of months ago, communication was received from ge healthcare acknowledging that the time sync on their devices is not working and that a manual sync is required.The time synch function does not work as intended.Communication was later received from ge healthcare regarding the mac vu360 not properly syncing to the network time protocol (ntp) server informing ce that there had been a partial fix with the last software release.The key information was that the carts cannot be turned off which only makes the fix a partial fix.Ge healthcare communicated that a software release will be coming out in quarter four to fix the issue.The current recommendation is to use the manual time on the ekg machines.

• Brand Name: MAC
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 8200 west tower avenue; milwaukee WI 53223
• MDR Report Key: 13314021
• MDR Text Key: 284188949
• Report Number: 13314021
• Device Sequence Number: 1
• Product Code: DPS
• 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: 01/20/2022,10/19/2021

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: Other
• Device Model Number: VU360
• 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: 01/20/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/21/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1