MAUDE Adverse Event Report: GE MEDICAL INFORMATION TECHNOLOGIES INC MAC 5500 EKG HD; ELECTROCARDIOGRAPH

Model Number MAC 5500

Device Problem Electromagnetic Interference (1194)

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

Event Date 06/14/2016

Event Type  malfunction  

Event Description

Staff note issues in obtaining clear ekgs.First one of the day is fine then the rest of the day they get worse.We replaced the older machine with a brand new and we are still having issues.It appears to be related to electrical interference.

• Brand Name: MAC 5500 EKG HD
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL INFORMATION TECHNOLOGIES INC; 8200 w tower ave; milwaukee WI 53222
• MDR Report Key: 5768592
• MDR Text Key: 48720973
• Report Number: 5768592
• 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: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: MAC 5500
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2016
• Device Age: 1 DY
• Date Report to Manufacturer: 07/01/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2016
• 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
• Treatment: NO