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

Model Number MAC 5500

Device Problems Connection Problem (2900); Device Operates Differently Than Expected (2913)

Patient Problem Cardiac Arrest (1762)

Event Date 02/09/2016

Event Type  Malfunction  

Event Description

After the patient was successfully resuscitated, a stat ekg was ordered due to cardiac arrest. The ekg machine did not function and alerted unable to connect.

• Brand Name: MAC 5500
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL INFORMATION TECHNOLOGIES, INC.; 465 pan american drive suite 11; el paso TX 79907
• MDR Report Key: 5459878
• MDR Text Key: 38979896
• Report Number: 5459878
• 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: User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/23/2016

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 02/25/2016
• Is This An Adverse Event Report?: Yes

Device Operator

• Device MODEL Number: MAC 5500
• 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: 02/23/2016
• Event Location: Hospital
• Date Report TO Manufacturer: 02/23/2016
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: No Answer Provided
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage