MAUDE Adverse Event Report: NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK) NATUS PHOTIC STIM KIT; PHOTIC STIMULATOR

Device Problems Electrical /Electronic Property Problem (1198); Sparking (2595)

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

Event Date 02/13/2016

Event Type  malfunction  

Manufacturer Narrative

Following natus complaint procedure, the photic system was investigated.The cable found broken at the end of lower arm.Normal wear and tear failure due to mechanical movement.

Event Description

During photic activation the power cable starting sparking.Photic power cable had exposed wires after sparks occured.No one was hurt.

• Brand Name: NATUS PHOTIC STIM KIT
• Type of Device: PHOTIC STIMULATOR
• Manufacturer (Section D): NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK); 2568 bristol circle; oakville, oakville ontario L6H 5 S1; CA L6H 5S1
• Manufacturer (Section G): NATUS MEDICAL INCORPORATED DBA EXCEL-TECH (XLTEK); 2568 bristol circle; oakville, ontario L6H5S 1; CA L6H5S1
• Manufacturer Contact: sanjay mehta ; 2568 bristol circle; oakville, ontario L6H5S-1 ; CA L6H5S1
• MDR Report Key: 8074454
• MDR Text Key: 128403747
• Report Number: 9612330-2018-00018
• Device Sequence Number: 1
• Product Code: GWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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