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

Model Number 5500 HD

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 07/15/2018

Event Type  malfunction  

Event Description

Patient seen in emergency room with complaints of shortness of breath, diaphoresis, chest pain, and headache.The nurse was attempting to get an ecg, but the mac 5500 hd gave an error message "limb lead disconnected".The nurse replaced the leads and attempted to get an ecg again, but the mac 5500 hd kept giving the same error message.The mac 5500 hd was replaced with another system, and the nurse was able to get an ecg.No untoward patient effects.

• Brand Name: MAC 5500 HD
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC; 9900 innovation drive; wauwatosa WI 53226
• MDR Report Key: 7796619
• MDR Text Key: 117572530
• Report Number: 7796619
• 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: 07/23/2018,07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5500 HD
• Device Catalogue Number: 018344
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14600 DA