MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED UPGRADE SLEEPWORKS 9.X ACQUISITION SOFTWARE WITH SPIKE / EVENT AND HIGH RES VIDE

Model Number	LC201-U9
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref natus complaint# (b)(4).Further investigation to be carried out.
Event or Problem Description
Part lc201-u9 upgrade sleepworks 9.X acquisition software with spike / event and high res video.Issue reported that when marking events on a patient in a review screen the events will also be added to a different patient in the live acquisition window.This could lead to an improper diagnosis.
Event or Problem Description
Part lc201-u9 upgrade sleepworks 9.X acquisition software with spike / event and high res video - issue reported that when marking events on a patient in a review screen the events will also be added to a different patient in the live acquisition window.This could lead to an improper diagnosis.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint# (b)(4).Install date: (b)(6) 2023.The issue is reproducable with neuroworks 9.3 gma2 and determined a software defect.The defect case (b)(4) was created to address the issue in future release of neuroworks.Faillure confirmed:yes.Investigation result code: neuro sbu|software failure.This complaint does not identify a deficiency in the product design and therefore a capa is not required per hazard id 5.62 in (b)(4) xltek eeg psg risk analysis, severity risk: 11 risk is considered to be moderate.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 (b)(4), complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Closure rationale: complalint verified, correction deferred to future product release.Complaint will be included in trending data for further review.

• Brand Name: UPGRADE SLEEPWORKS 9.X ACQUISITION SOFTWARE WITH SPIKE / EVENT AND HIGH RES VIDE
• Common Device Name: UPGRADE SLEEPWORKS 9.X ACQUISITION SOFTWARE WITH SPIKE / EVENT AND HIGH RES VIDE
• 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, H91PD 92; EI H91PD92
• Manufacturer Contact: gráinne walsh ; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios,, L6H 5-S1 ; CA L6H 5S1
• MDR Report Key: 17277861
• Report Number: 9612330-2023-00016
• Device Sequence Number: 14748562
• Product Code: OSN
• UDI-Device Identifier: 00382830059541
• UDI-Public: 00382830059541
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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
• Operator of Device: Health Professional
• Device Model Number: LC201-U9
• Device Catalogue Number: LC201-U9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown