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

Model Number 5500

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Atrial Fibrillation (1729); Tachycardia (2095)

Event Date 05/15/2015

Event Type  malfunction  

Event Description

The pt.Was in rapid arterial fibrillation, heartrate was between 150-160 bpm; attempted by the nurses to do an ecg but the machine did not work.It is saying "terminating connection".The machine was disconnected.Orders won't even load.

• Brand Name: MAC 5500
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES; 9900 w. innovation drive; wauwatosa WI 53226
• MDR Report Key: 5017609
• MDR Text Key: 23536805
• Report Number: 5017609
• 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
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 5500
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2015
• 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: 74 YR