MAUDE Adverse Event Report: GENERAL ELECTRIC CO. 12 LEAD ECG MONITOR; TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 05/18/2021

Event Type  malfunction  

Event Description

Patient was here for a scheduled treadmill echo stress test.Patient started test without difficulty and then began reporting sharp, pinching pain to right hip area after walking on the treadmill after 6min.Treadmill stopped per rn, and found ecg 12 lead monitor box with plastic separated from monitor belted around patient's waist.Monitor found pinching patient's right flank area.Skin, slightly red, intact, and without bruising.Ecg monitor removed from patient's hip, new monitor applied to patient's waist, and time restarted.

• Brand Name: 12 LEAD ECG MONITOR
• Type of Device: TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE
• Manufacturer (Section D): GENERAL ELECTRIC CO.; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 12049024
• MDR Text Key: 257736583
• Report Number: 12049024
• Device Sequence Number: 1
• Product Code: DXH
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 05/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Weight: 75