MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MAC 5500; ELECTROCARDIOGRAPH

Model Number 5500

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2015

Event Type  malfunction  

Event Description

The pt.Needs an ecg after sotalol medication.We placed the order in (b)(6) but it will not upload into the ecg machine.We tried both machines.

• Brand Name: MAC 5500
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 8200 west tower ave.; milwaukee WI 53223
• MDR Report Key: 4972899
• MDR Text Key: 22029511
• Report Number: 4972899
• Device Sequence Number: 1
• Product Code: DPS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/02/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2015
• Patient Sequence Number: 1
• Patient Age: 74 YR