MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED ELC/DISP DISK W 2M LEAD 60,DIN

Model Number 019-409000

Device Problem Product Quality Problem (1506)

Patient Problem Burn(s) (1757)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

(ref (b)(4)) the customer is having some problem with the adhesive electrodes.They are causing burns on some of the patient's skin.The customer advised that the patient has a round burn mark on the right side of their forehead which is the same shape as the electrode.The hospital's wound care was called to treat the newborn patient.The customer advised that they are aware of the event happening on at least 3 patients.The burn marks are always on the forehead and sometimes it happens on one side and sometimes on both electrode placement sites.19-january 2021 - 9 boxes of electrodes were received back for investigation.

Event Description

Issues with the adhesive electrodes.They are causing burns to some of the patient's skin.

Event Description

Issues with the adhesive electrodes.They are causing burns to some of the patient's skin.

Manufacturer Narrative

Follow up 001 (ref natus complaint# (b)(4)) investigation details: the used electrodes were not returned for evaluation.The customer provided unused electrodes.These unused electrodes were tested by cleaning patients arm, applying and reapplying electrodes with no evident burns or marks.Electrodes produced signal, electrodes are functioning as intended.There have been no recent changes to product.Capa and complaint trending review: there are no capa's related to this issue and this complaint does not identify a deficiency in the product design and therefore a capa is not required.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.No complaint trend has been identified.Risk review: per doc-019991 rev 07 adhesive electrode risk analysis file, hazard id - 13.1, hazard - adhesive on the electrode causes wounds burn on the patient skin, severity - 3, residual risk acceptable.Final review of investigation details to be completed, before closure.

Event Description

Issues with the adhesive electrodes.They are causing burns to some of the patient's skin.

Manufacturer Narrative

Follow up 002 (ref natus complaint# (b)(4)).Investigation details: the used electrodes were not returned for evaluation.The customer provided unused electrodes.These unused electrodes were tested by cleaning patients arm, applying and reapplying electrodes with no evident burns or marks.Electrodes produced signal, electrodes are functioning as intended.There have been no recent changes to product.The ifu contains a caution regarding skin redness for prolonged use and indicates use at the discretion of the trained medical professional.The risk for redness is typically higher in newborns when used in multi-day studies.The user should not use "10/20 conductive paste 10-20-8 or tensive gel.The electrodes are pre-gelled.Natus notified the user and instructed them not to use conductive paste or gels and provided the warning of using these electrodes for long term use on newborns or skin irritation can occur.Capa and complaint trending review: there are no capa's related to this issue and this complaint does not identify a deficiency in the product design and therefore a capa is not required.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.No complaint trend has been identified.Risk review: per doc-019991 rev 07 adhesive electrode risk analysis file, hazard id - 13.1, hazard adhesive on the electrode causes wounds burn on the patient skin severity 3, residual risk acceptable 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.Investigation result code :neuro sbu|no issues noted.

• Brand Name: ELC/DISP DISK W 2M LEAD 60,DIN
• Type of Device: ELC/DISP DISK W 2M LEAD 60,DIN
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 3150 pleasant view road; middleton, 53562 WA
• MDR Report Key: 11205511
• MDR Text Key: 229088664
• Report Number: 3010611950-2021-00001
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• PMA/PMN Number: K850108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 019-409000
• Device Catalogue Number: 019-409000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 01/13/2021; 01/13/2021
• Supplement Dates FDA Received: 02/18/2021; 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 DA