MAUDE Adverse Event Report: NATUS NEUROLOGY, INCORPORATED NATUS EDX ELECTROMYOGRAPH SYSTEM

Model Number 982A0597

Device Problems Defibrillation/Stimulation Problem (1573); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem Misdiagnosis (2159)

Event Date 07/27/2016

Event Type  Injury  

Manufacturer Narrative

This adverse event was registered internally as a complaint (reference (b)(4)) for further investigation by natus.Based on a service call initiated on july 20, 2016, the customer requested that a natus field service representative perform an onsite evaluation of the equipment but continued to use the equipment.The field service representative evaluation occurred on july 29, 2016 and found that the emg system base was not functioning properly.On that date, the customer informed the field service representative of this adverse event.The device history record for emg system serial number (b)(4) was reviewed.All the system components met the manufacturing specifications at the time of release.Product componentry was returned to natus for further evaluation and found that a transformer had failed within the base unit which resulted in the reduction of the electrical stimulation function of the system.Patient files supplied by the customer were evaluated by a trained clinician.A risk assessment performed by natus personnel concluded that input and output functions were inconsistent with expected results that trained users should recognize.Regarding the patient in question, following an initial request for information made on august 4, 2016, the customer reported on (b)(6) 2016 that no actual medical intervention was required.

Event Description

Customer reported that their emg system is not getting any motor responses and stimulation sensories are low.This may have resulted in a misdiagnosis for the patient.

• Brand Name: NATUS EDX ELECTROMYOGRAPH SYSTEM
• Type of Device: ELECTROMYOGRAPH SYSTEM
• Manufacturer (Section D): NATUS NEUROLOGY, INCORPORATED; 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: 5901498
• MDR Text Key: 52940798
• Report Number: 3010611950-2016-00010
• 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: Physician
• Type of Report: Initial
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 982A0597
• Device Catalogue Number: 982A0597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2016
• 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: 73 YR
• Patient Weight: 164