MAUDE Adverse Event Report: EMBLA SYSTEMS S4500 BEDSIDE UNIT; ELECTROENCEPHALOGRAPH

Model Number 2000204

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

There was no shock mark and there was no shock complaint from the patient at the time of the event.Following natus complaint procedure, natus has requested the device back for investigation and has not yet received it.No findings available at this moment.Replacement provided to the customer.

Event Description

Patient experienced shock(s) while doing sleep study with mdrive and s4500 bu.Patient called after 2 weeks to know why the electrode gave him shock in the night when they went into the room.There was no shock mark and there was no shock complaint at the time it happened.

Manufacturer Narrative

The device was returned and evaluated by natus on august 15, 2019.Investigation results concluded that the device was working as intended.

• Brand Name: S4500 BEDSIDE UNIT
• Type of Device: ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): EMBLA SYSTEMS; 1 hines road; suite 202; kanata, K2K 3 C7; CA K2K 3C7
• MDR Report Key: 9087588
• MDR Text Key: 216763770
• Report Number: 3005888786-2019-00001
• Device Sequence Number: 1
• Product Code: MNR
• Combination Product (y/n): N
• PMA/PMN Number: K111742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

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: Health Professional
• Device Model Number: 2000204
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 04/16/2019
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other