MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED BRAIN MONITOR BASE UNIT

Model Number 10388

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem Blister (4537)

Event Date 11/18/2022

Event Type  malfunction  

Manufacturer Narrative

Initial report ref to natus complaint#: (b)(4).Tpi-2934 is created for engineering investigation.It was noted that - this is not normal outcomes.No current goes from the breakout box to the patient.Clinical team to speak with the client to understand their workflow.Further follow up's to be carried out with ref to the gel or cream used to prepare the skin and the electrodes.There are no capa's related to this issue.This complaint does not identify a deficiency in the product design and therefore a capa is not required.Per doc-010378 hazard id.9.9, severity 3-marginal, risk level 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.Device history record was reviewed, and no related faults/issue found.Document (b)(4), production order number: 11243 install date: on 04-dec-2019.

Event Description

Part 10388 brain monitor base unit- client advised they have had patients with skin breakdown after having an extended (24hr or more) eeg study.According to the questionnaire responses, the patient had small blister, scrapes on the forehead and behind the ears, requiring a wound care consultation.Nuprep and alcohol were used to clean patient skin prior to procedure.10/20 cream was used in conjunction with the electrodes.

Manufacturer Narrative

Follow up report 001 ref to natus complaint#(b)(4) several attempts were made to contact the customer.Customer responded that the problems they were seeing have decreased substantially.Customer believes preparation changes have been made.No further investigation to be carried out.Failure confirmed: no ·.

Event Description

Part 10388 brain monitor base unit- client advised they have had patients with skin breakdown after having an extended (24hr or more) eeg study.According to the questionnaire responses, the patient had small blister, scrapes on the forehead and behind the ears, requiring a wound care consultation.Nuprep and alcohol were used to clean patient skin prior to procedure.10/20 cream was used in conjunction with the electrodes.

• Brand Name: BRAIN MONITOR BASE UNIT
• Type of Device: BRAIN MONITOR BASE UNIT
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd. (xltek); 2568 bristol circle; oakville, ontario l6h 5s1, ; CA
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: walsh ; dba excel-tech ltd. (xltek); 2568 bristol circle; oakville, ontario l6h 5s1, ; CA
• MDR Report Key: 15938518
• MDR Text Key: 308013492
• Report Number: 9612330-2022-00052
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 00382830002523
• UDI-Public: 00382830002523
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

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: 10388
• Device Catalogue Number: 10388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 11/18/2022
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White