MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED SLEEPWORKS 9.X ACQUISITION SOFTWARE WITHOUT SPIKE / EVENT

Model Number LC200-9

Device Problem Computer Software Problem (1112)

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

Event Date 08/08/2023

Event Type  malfunction  

Manufacturer Narrative

Initial report ref natus complaint# (b)(4).Technical support noted all apneas were in sleep stage and were present in scored epoch.They re-analyzed study and regenerated the report, but was still showing incorrect value.They tried creating new template for central apneas but it also showed incorrect value.It was suspected a bug in variables and escalated issue to engineering.Engineering was able to re-produce the issue.Created the defect nw-24471.They were requested to follow up with developer working on nw-24471 to provided update on root cause.There are no capa's related to this issue.(b)(4), complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Udi / serial number: not applicable.Awaiting investigation results.

Event Description

Part lc200-9 sleepworks 9.X acquisition software without spike: customer states that reports are showing incorrect count for central apnea.

Manufacturer Narrative

Follow up report 001 ref natus complaint (b)(4) engineering has determined the root cause of this issue.If an artifact event is drawn on the body position channel (bp) the specific variable that is incorrect in the report is excluding events that are present during this artifact time.Next step advised by engineering: advise customer that root cause has been determined find out why they are creating artifact events on bp educate the customer on the correct workflow to edit incorrect bp final review and approval of investigation results to be completed before final closure.

Event Description

Part lc200-9 sleep works 9.X acquisition software without spike: customer states that reports are showing incorrect count for central apnea.

Manufacturer Narrative

Follow up report 002 ref natus complaint# (b)(4).Final review and approval of the below investigation details was completed, and the complaint case is now closed.Risk review: (b)(4) rev 01 post market risk assessment states: no hazards identified.The report values are based on software variables and the count of central apneas is affected when an artifact is marked on bp (body position).Marking of artifacts on bp is use error and rare occurrence.Ahi (apnea hypopnea index) doesn't exclude the events occurring when artifacts is marked on bp.Therefore, the count of central apnea used to calculate ahi in the report is correct and does not exclude the events occurring when artifacts is marked on bp.Investigation summary - root cause: engineering has determined the root cause of this issue.If an artifact event is drawn on the body position channel (bp) the specific variable that is incorrect in the report excludes events that are present during this artifact time.Recommended actions: defect# nw-24471 was created.The issue will be addressed in future build of sleepworks.Note, use error, a rare occurrence, and natus was able to replace all the above variables with the customers alternative version that can be found under the tables category and these showed the correct number of 25 events.All details and variables used can be seen in the report template.Reported issue related to user error.The artfact issue was discovered while investigating the customer's incorrect marking of artifacts on bp.There are no capa's related to this issue.Software bug will be fixed with neuroworks 10.0 gma2 and neuroworks 9.3 gma3.Udi (b)(4).Closure rationale: complalint verified, correction deferred to future product release.Complaint will be included in trending data for further review.

Event Description

Part lc200-9 sleepworks 9.X acquisition software without spike: customer states that reports are showing incorrect count for central apnea.

• Brand Name: SLEEPWORKS 9.X ACQUISITION SOFTWARE WITHOUT SPIKE / EVENT
• Type of Device: SLEEPWORKS 9.X ACQUISITION SOFTWARE WITHOUT SPIKE / EVENT
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, l6h 5s1, ; CA
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, l6h 5s1, ; CA
• MDR Report Key: 17573905
• MDR Text Key: 321472378
• Report Number: 9612330-2023-00030
• Device Sequence Number: 1
• Product Code: OLZ
• UDI-Device Identifier: 00382830047210
• UDI-Public: 00382830047210
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090277
• 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,Followup
• Report Date: 11/10/2023
• 2 Devices were Involved in the Event: 1 2

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: LC200-9
• Device Catalogue Number: LC200-9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 08/08/2023; 08/08/2023
• Supplement Dates FDA Received: 09/13/2023; 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other