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

Model Number 019-409000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Skin Discoloration (2074); Lead(s), Burn(s) From (3161)

Event Type  Injury  

Manufacturer Narrative

Justification for not providing below information and applicable sections: no patient injury reported, device malfunction occurred.Date of event requested from the customer but information not yet provided.There was no action reported under 21usc 360i(f).Investigation results and findings: dhr review: no lot number provided, therefore dhr review unavailable at this time.Risk management file review: per (b)(4) rev 03, hazard id: 7.1 (patient allergic to one or more of the constituents of the electrode), severity 3, acceptable risk -no capa 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.

Event Description

Elc/disp disk w 2m lead 60,din - the customer's patient allegedly experienced burn marks on the electrode site.

Manufacturer Narrative

Update 14 may 2020 product examination and functional testing: customer confirmed they disposed of the product, therefore unable to test the product.Capa 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.Complaint trending review: per (b)(4) complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.No complaint trends have been identified.Risk management file review: per doc-019991 rev 02, hazard id: 7.1, severity - 3, acceptable risk.Service record review: service repair investigations will be conducted during the repair process and trend data will be reviewed per (b)(4).No death, superficial injury to customer's skin.Justification for not providing below information and applicable sections: a: patient information - no patient injury information was provided.B3: date of event - date of event requested from the customer but this information was not provided.B6: relevant tests / laboratory data - this section is not applicable, this information was not provided.B.7 other relevant history, including preexisting medical conditions: this section is not applicable, this information was not provided.C: suspect products - not applicable d4: lot/serial # - requested from the customer but information not provided d4 expiration date (dd-mmm-yyyy) requested from the customer but information not provided d4 unique identifier (udi) # requested from the customer but information not provided d.6: if implanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable.D.7 if explanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable.D.9 reprocessor name and address - this section is not applicable as the medical device is not a single-use device that was reprocessed or reused on a patient.D.11 concomitant medical products and therapy dates (excluding treatment of event) - this section is not applicable to this type of device f: for use by user facility / importer - not applicable as we are not a facility or importer of device.G.6 if ind, give protocol # - this section is not applicable as the medical device is not ind.G.8 adverse event terms - this section is not applicable to medical devices.H4 device manufacture date (dd-mmm-yyyy) lot/serial no.Was not provided by the customer therefore unable to determine manufacture date.H.7 if remedial action initiated , check type - this section is not applicable as no remedial action was initiated.H.9 if action reported to fda under 21 usc 360i (f), list correction / removal reporting number - this section is not applicable as there was no action reported under 21usc 360i(f).

Event Description

Elc/disp disk w 2m lead 60,din - the customer's patient allegedly experienced burn marks on the electrode site.

• 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 NEUROLOGY INCOPORATED; 3150 pleasant view road; middleton,53562, wi
• MDR Report Key: 9986346
• MDR Text Key: 229014209
• Report Number: 3010611950-2020-00010
• 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
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 019-409000
• Device Catalogue Number: 019-409000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 04/07/2020
• Supplement Dates FDA Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other