MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MACVU 360 ECG MACHINE; ELECTROCARDIOGRAPH

Model Number MACVU 360

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 10/13/2023

Event Type  malfunction  

Event Description

Emergency department nurse grabbed a ge macvu 360 ecg machine to use on patient for a 12 lead analysis.She touched the acquisition cable and it was hot and began to melt.This resulted in a superficial burn on her finger.This prompted an inspection of the remaining 3 machines in their department and a second machine with a melted cable was found.From there it prompted an internal inspection of this cable on our entire fleet of this model.We found 6 more cables that were bulging in the place where the other two melted.Ref report: mw5148057, mw5148059, mw5148060.

• Brand Name: MACVU 360 ECG MACHINE
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• MDR Report Key: 18123198
• MDR Text Key: 328226975
• Report Number: MW5148058
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MACVU 360
• Device Catalogue Number: 2088554-004
• Device Lot Number: 713915041121
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other