MAUDE Adverse Event Report: CERIBELL, INC. POCKET EEG DEVICE; AUTOMATIC EVENT DETECTION SOFTWARE FOR FULL-MONTAGE ELECTROENCEPHALOGRAPH

Model Number C100

Device Problem Communication or Transmission Problem (2896)

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

Event Date 03/04/2023

Event Type  malfunction  

Event Description

Ceribell eeg monitor appropriately placed on patient would not transmit a report with confirmed wi-fi connection.

• Brand Name: POCKET EEG DEVICE
• Type of Device: AUTOMATIC EVENT DETECTION SOFTWARE FOR FULL-MONTAGE ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): CERIBELL, INC.; 360 n pastoria ave; sunnyvale CA 94085
• MDR Report Key: 16938498
• MDR Text Key: 315293481
• Report Number: 16938498
• Device Sequence Number: 1
• Product Code: OMB
• 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: 04/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: C100
• Device Lot Number: L10188
• 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: 04/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Sex: Male
• Patient Race: White