MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED MOBILE CART CAMERA

Model Number 10295

Device Problems Device Damaged Prior to Use (2284); Defective Device (2588)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

Mobile cart camera has fallen on the eeg technician head.

Event Description

Mobile cart camera fell on the eeg technician head.

Event Description

Mobile cart camera fell on the eeg technician head.

Manufacturer Narrative

Update 07th may 2020: investigation results & findings (natus complaint ref.# 1-702493582).Risk review: per doc-010378 - eeg/psg risk analysis, hazard id - 6.4 identifies "system cart or peripherals fall or tip onto patient or user when cart is idle, in motion, or during attempt to traverse a threshold or obstacle." the risk is considered moderate.Upon evaluation of the unit, it was noted that the mounting tread on both sides of the camera are completely destroyed which would have been caused by misaligning the camera and pole when the camera was mounted.The destruction of the bottom tread suggests that an attempt was made to mount it on the pole.The lack of a secure, ridged assembly between the camera and carts pole could result in the camera falling off the cart.A replacement unit has been sent to the customer.The complaint as reported was verified.This has been deemed an isolated incident and will continue to be monitored for future occurrence.

Event Description

Mobile cart camera fell on the eeg technician head.

Manufacturer Narrative

Update 09th april 2020 manufacturers internal report ref.# (b)(4).Investigation results & findings the suspect device has been returned for evaluation.Investigation is in progress.

• Brand Name: MOBILE CART CAMERA
• Type of Device: MOBILE CART CAMERA
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd. (xltek); 2568 bristol circle; oakville, ontarios L6H 5 S1; CA L6H 5S1
• MDR Report Key: 9805143
• MDR Text Key: 200609000
• Report Number: 9612330-2020-00003
• Device Sequence Number: 1
• Product Code: FTT
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10295
• Patient Sequence Number: 1