MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED EMBLETTA MPR PG

Model Number 2003011

Device Problem Accessory Incompatible (1004)

Patient Problem Blister (4537)

Event Date 01/12/2023

Event Type  malfunction  

Event Description

Embletta mpr pg - patient had burning/blisters between electrodes used with mpr system.No medical intervention was required to treat skin burns/blisters.

Manufacturer Narrative

Initial report ref to natus complaint# (b)(4).Customer reported to natus that a child had exhibited 'burning' - two blisters - on his skin after an overnight study with an embletta on (b)(6) 2023.Hospital staff made a diagram of where the blisters appeared relative to the electrode placement.Pictures provided.Injury (burning.Blisters) described as being between the electrodes.Electrode description - blue sensor ambu eec electrodes.Device was being used for overnight sleep study and was connected to patient for roughly 12 hours.The following items were being used with embletta mpr pg: xpod - s/n (b)(4).Abdomen lock - lot no.2020-03-20.Thorax lock - lot no.2020-03-20.Red, green, black, blue, yellow electrodes.Patient skin was not confirmed to be cleaned before procedure.No conductive gel was used.Acceptable risk associated with the complaint per hazard id 9.4 of (b)(4) embla risk analysis spreadsheet, 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.There are no capa's related to this issue.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.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: (b)(6) 2020.Requested for customer to return the embletta mpr involved as well as the electrodes and asked for part number of electrodes that were used.Further investigation to be carried out.

Manufacturer Narrative

Follow up report 001 ref to natus complaint#(b)(4) the customer returned the affected parts.26 april 2023 - engineering investigation results summary: sensors and electrodes had no observed damaged from heat or overheating.Plastic and wires did not have any deformation.Electrode contact had no heat damage or identification of wear from heat.Unit was functional tested and reviewed for behavior during performance.Electrodes were not observed to heat up or deform during testing.Unit was functionally tested at the system level with the p&q test.Units was also programmed to conduct short studies, with sensors.Studies began and started as they were programmed.Studies were successfully completed; unit and electrodes did not overheat.Root cause: the mpr unit investigated performance requirements and testing demonstrated the hardware and sensor were not the root cause observed in this case.Unit was tested per the product and functional requirements; no malfunction observed during testing.The observed blistering was not induced by the mpr system.Failure confirmed: no investigation result code: neuro sbu|no issues noted closure rationale: complaint could not be verified, monitor for future occurrence.Complaint will be included in trending data for further review.

Event Description

Embletta mpr pg - patient had burning/blisters between electrodes used with mpr system.No medical intervention was required to treat skin burns/blisters.

• Brand Name: EMBLETTA MPR PG
• Type of Device: EMBLETTA MPR PG
• 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: 16452459
• MDR Text Key: 310427794
• Report Number: 9612330-2023-00001
• Device Sequence Number: 1
• Product Code: MNR
• UDI-Device Identifier: 00382830023764
• UDI-Public: 00382830023764
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

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: 2003011
• Device Catalogue Number: 2003011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2019
• 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 Age: 7 YR
• Patient Sex: Female