MAUDE Adverse Event Report: EMPATICA S. R. L. EMBRACE2; PHYSIOLOGICAL SIGNAL BASED SEIZURE MONITORING SYSTEM

Model Number EM2-MB-S

Device Problems Defective Alarm (1014); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Convulsion/Seizure (4406)

Event Date 10/08/2021

Event Type  Injury  

Event Description

My seizure detection watch, an fda approved device failed to alert during a seizure.The error reported on my phone was 'server error, alert not sent'.Nobody knew i had a seizure.The app obviously knew i had a seizure and tried to report it, but there was a malfunction on empaticas side.Fda safety report id # (b)(4).

• Brand Name: EMBRACE2
• Type of Device: PHYSIOLOGICAL SIGNAL BASED SEIZURE MONITORING SYSTEM
• Manufacturer (Section D): EMPATICA S. R. L.
• MDR Report Key: 12633240
• MDR Text Key: 276677538
• Report Number: MW5104600
• Device Sequence Number: 1
• Product Code: POS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EM2-MB-S
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 20 YR
• Patient Weight: 73