MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED SLEEPWORKS 7.X ACQUISITION SW WITH SPIKE / EVENT AND HIGH RES VIDEO

Model Number LC201-7

Device Problem Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2022

Event Type  malfunction  

Event Description

Customer stated there is an issue with one of the sleep cameras "over heating" and not responding to the camera controls (moves around in circles per customer).No injuries reported.

Manufacturer Narrative

Initial report ref to natus complaint #(b)(4).Customer unable to provide any identifying information on device.Unable to look asset up.Instructed customer where he can find the information on the camera.Customer will call back when he has that information.Unable to remote into sleep system.Customer stated that is locked down, he is also not near the sleep lab.24-mar-2022: questionnaire sent to the customer.28-mar-2022: second follow up made.No response from customer.Further investigation to be carried out.

Manufacturer Narrative

Follow up report 001 (ref to natus complaint# (b)(4)).It was requested that the device be returned for evaluation.The camera is at least 12 years old and was discarded by the customer when they were advised there were no repair possibilities for it.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 (b)(4), complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Per (b)(4) hazard id line 5.22, 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.A device history 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.Udi number: not applicable.Faillure confirmed: no.Investigation result code: neuro sbu|product not returned.Closure rationale:complaint could not be verified, materials not returned for analysis.Low risk of harm or safety, individual complaint related to issue stated.No death or serious injury, considered a customer inconvenience.Complaints will be included in trending data for further review and investigation if needed.

Event Description

Customer stated there is an issue with one of the sleep cameras "over heating" and not responding to the camera controls (moves around in circles per customer).No injuries reported.

• Brand Name: SLEEPWORKS 7.X ACQUISITION SW WITH SPIKE / EVENT AND HIGH RES VIDEO
• Type of Device: SLEEPWORKS 7.X ACQUISITION SW WITH SPIKE / EVENT AND HIGH RES VIDEO
• 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: 13950160
• MDR Text Key: 298231421
• Report Number: 9612330-2022-00017
• Device Sequence Number: 1
• Product Code: OLZ
• 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
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

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: LC201-7
• Device Catalogue Number: LC201-7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 05/23/2022
• 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: Reuse
• Patient Sequence Number: 1