MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES EKG, MULTI CHANNEL, INTERPRETATIVE - GE MEDICAL SYSTEMS BIO MED - MAC 5500; ELECTROCARDIOGRAPH

Model Number MAC 5500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Burning Sensation (2146)

Event Date 01/04/2022

Event Type  Injury  

Event Description

While performing patient's ekg, patient noted a "burning" sensation when i placed the v6 lead.This was removed immediately, and small burn mark was noted on patient's left side.Physician notified of this, and did evaluate patient.Physician stated, "small area of redness on his chest wall." fda safety report id# (b)(4).

• Brand Name: EKG, MULTI CHANNEL, INTERPRETATIVE - GE MEDICAL SYSTEMS BIO MED - MAC 5500
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
• MDR Report Key: 13205979
• MDR Text Key: 283609699
• Report Number: MW5106530
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/05/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MAC 5500
• Device Catalogue Number: CE TAG # A26477 / 50661755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1