MAUDE Adverse Event Report: BIOTEL / BRAEMAR MANUFACTURING, LLC. BIOTEL MCOT; DETECTOR AND ALARM, ARRHYTHMIA

Model Number MT29044046

Device Problems Failure to Sense (1559); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

Device switched to cellular use and did not capture ekg on pt.A 42 y/o male pt received biotel mcot device to monitor cardiac issues.On (b)(6) 2022, pt presented to the cardiology office with monitor issues.Upon investigation, it was determined that the monitor switched back to cellular mode.Biotel rep was notified and advised to send the original to biotel and they will send pt a new monitor.No injuries to the pt.

• Brand Name: BIOTEL MCOT
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): BIOTEL / BRAEMAR MANUFACTURING, LLC.
• MDR Report Key: 16052876
• MDR Text Key: 306327959
• Report Number: MW5114027
• Device Sequence Number: 1
• Product Code: DSI
• 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: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT29044046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Ethnicity: Hispanic