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

Model Number 5500 HD

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 08/06/2020

Event Type  malfunction  

Event Description

The leads were appropriately attached to the patient; however, the machine was not recognizing the right-side leads attached to the patient.

• Brand Name: MAC 5500 HD
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 8200 west tower avenue; WI 53223
• MDR Report Key: 10390074
• MDR Text Key: 202375703
• Report Number: 10390074
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5500 HD
• Device Catalogue Number: 2053900-001
• 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: 08/07/2020
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1