MAUDE Adverse Event Report: \GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MACUVE360; ELECTROCARDIOGRAPH

Model Number MACUVE360

Patient Problem Insufficient Information (4580)

Event Date 11/20/2023

Event Type  Injury  

Event Description

There is a delay in part order that resulted in delay in repairing the macvue360 (serial# (b)(6)) unit and put the unit back to service for patient use.

• Brand Name: MACUVE360
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): \GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• MDR Report Key: 18384000
• MDR Text Key: 331346101
• Report Number: MW5149478
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): Y
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MACUVE360
• Device Catalogue Number: 2220000-104
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: MAC VU360 CAM, ADD ON, AHA W/LEADWIRES, BANANA ADAPTERS.
• Patient Outcome(s): Required Intervention