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

Model Number 2026609-001

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Date 09/10/2020

Event Type  malfunction  

Event Description

The ekg device display intermittently blanks out.No display.

• Brand Name: MAC 5500
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 10778134
• MDR Text Key: 214345463
• Report Number: 10778134
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2026609-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2020
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1