MAUDE Adverse Event Report: NATUS NEUROLOGY INCOPORATED VIKING EDX INTERNATIONAL

Model Number 982A0568

Device Problem Insufficient Information (3190)

Patient Problem Localized Skin Lesion (4542)

Event Date 08/19/2022

Event Type  malfunction  

Manufacturer Narrative

Initial report ref natus complaint#(b)(4).Service technician spoke with the customer and requested that they no longer use the system until a natus field service technician has been onsite to test the system.Per information received: patient involved :yes.Alleged injury: yes.Alleged delay in treatment: yes.Alleged environmental or safety issue: yes.25-august-2022: a requested that a adverse event questionnaire be sent to the customer.Further review of investigation details to be carried out.

Event Description

Viking edx international - the customer reports there was skin lesions after application and requested that the device be checked for error currents.

Manufacturer Narrative

Follow up report 001 ref natus complaint#(b)(4) a natus field service technician visited the customer to check the system.The system was checked for safety, and no issue was found.Capa trending review: this complaint does not identify a deficiency in the product design and therefore a capa is not required per (b)(4) emg-iom risk analysis file, hazard id - 10.2, severity 3 - marginal, the risk is considered low.A risk review is not required as this complaint does not describe a new failure mode or new harm and the existing hazard severity and/or probability of occurrence has not changed.Per qms-004442, complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews a device history record review is not applicable because, prior to the reported issue the device was in service for 2 or more years and a manufacturing defect is very unlikely.Install date: march 26, 2016."failure" confirmed: no.Investigation result code: neuro sbu|no issues noted.

Event Description

Viking edx international - the customer reports there was skin lesions after application and requested that the device be checked for error currents.

• Brand Name: VIKING EDX INTERNATIONAL
• Type of Device: VIKING EDX INTERNATIONAL
• Manufacturer (Section D): NATUS NEUROLOGY INCOPORATED; 3150 pleasant view road; middleton, 53562 WI
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; 3150 pleasant view road; middleton, 53562, WI
• MDR Report Key: 15319398
• MDR Text Key: 305246833
• Report Number: 3010611950-2022-00003
• Device Sequence Number: 1
• Product Code: IKN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K890495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 982A0568
• Device Catalogue Number: 982A0568
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2022
• 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: Initial
• Patient Sequence Number: 1