MAUDE Adverse Event Report: NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK) ERGOJUST CART - VIDEO EXTENSION; ELECTROENCEPHALOGRAPH

Model Number IP-EC-DT-CART-EXP

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

This incident was due to a weld failure, this malfunction was previously investigated by natus and field corrective action was initiated.The customer was informed about the issue and part of resolution a bracket kit was provided.During the follow up of our fca , customer had confirmed that provided bracket kit has been installed, however it was never installed.Following this incident.A new bracket kit along with installation instruction has been sent to the customer.

Event Description

Video extension fell off and hit a technician on the head.She was not injured according to the person who reported the event.This incident was due to a weld failure, a malfunction previously investigated under capa(b)(4).There is a fca implemented under capa(b)(4).Customer was sent the ergojust fca bracket kit and had confirmed installation under the fca sr (b)(4) on (b)(6) 2019.On 08-jul-2019 natus field service relayed new information from the customer.They requested we re-send the ergojust fca bracket kit and noted they had never installed them previously, despite the health care facility had confirmed during our fca follow up that bracket kit has been installed.

• Brand Name: ERGOJUST CART - VIDEO EXTENSION
• Type of Device: ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK); 2568 bristol circle; oakville, L6H 5 S1; CA L6H 5S1
• Manufacturer (Section G): NATUS MEDICAL INCORPORATED DBA EXCEL-TECH (XLTEK); 2568 bristol circle; oakville, L6H5S 1; CA L6H5S1
• Manufacturer Contact: sanjay mehta ; 2568 bristol circle; oakville, ontario L6H5S-1 ; CA L6H5S1
• MDR Report Key: 8778440
• MDR Text Key: 201374608
• Report Number: 9612330-2019-00005
• Device Sequence Number: 1
• Product Code: GWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IP-EC-DT-CART-EXP
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other