MAUDE Adverse Event Report: NATUS NEUROLOGY, INCORPORTAED NATUS VIKING SELECT; ELECTROMYGRAPH

Model Number 982A0403

Device Problems Device-Device Incompatibility (2919); Compatibility Problem (2960)

Patient Problems Burn(s) (1757); Injury (2348); Burn, Thermal (2530)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

Registered internally as a complaint (reference (b)(4)) for further investigation by manufacturer.One day after the incident was reported, the equipment indicated was evaluated on site by a trained natus field service technician, tested, and found to be operating within specification.Electro-cautery equipment was in use by the complainant at the same time as the natus device in question.There are known risks associated with such device to device combinations where electrodes can intercept stray radio frequency energy and result in thermal heating.Natus safety information supplied to end users states such interactions exist and warns end users that electrode disconnection may be needed to avoid such interactions (ref natus safety reference guide, label # (b)(4)).A separate mdr is being filed for the electrodes in use at the time of the incident (ref mdr 3010611950-2016-00003).

Event Description

Customer reported a patient received an electrode burn while using a natus viking select oem system, pn 982a0403, sn (b)(4).Customer also reported that electro-cautery equipment (not a natus device) was in use at the same time the viking select system was in use.

• Brand Name: NATUS VIKING SELECT
• Type of Device: ELECTROMYGRAPH
• Manufacturer (Section D): NATUS NEUROLOGY, INCORPORTAED; 3150 pleasant view road; middleton WI 53562
• Manufacturer (Section G): NATUS NEUROLOGY INCORPORATED; 3150 pleasant view road; middleton WI 53562
• Manufacturer Contact: randall moog ; 3150 pleasant view road; middleton, WI 53562 ; 6088298802
• MDR Report Key: 5452447
• MDR Text Key: 38744004
• Report Number: 3010611950-2016-00002
• Device Sequence Number: 1
• Product Code: IKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 982A0403
• Device Catalogue Number: 982A0403
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2011
• 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
• Patient Age: 15 YR
• Patient Weight: 40