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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 103