MAUDE Adverse Event Report: NATUS MEDICAL DENMARK APS ACCUSCREEN ABR/DP TYPE 1077

Model Number	8-04-13932
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref natus complaint#(b)(4).Natus medical accuscreen abr/dp type 1077 - false screening results.E-mail received the (b)(6) 2022 from health canada requesting additional information and stating the below information: this is to follow a report submitted to health canada involving the above noted device regarding an incident in which false negative screening results were received from testing an infant who, upon further investigation, was in fact found to have a hearing impediment.The reporter wishes to remain anonymous at this time.No part no.Or lot number provided.Udi no.To be confirmed.Further investigation to be carried out.
Event or Problem Description
Natus medical accuscreen abr/dp type 1077 - false screening results.Reported incident in which false negative screening results were received from testing an infant who, upon further investigation, was in fact found to have a hearing impediment.The reporter wishes to remain anonymous at this time.
Additional Manufacturer Narrative
Follow up report 002 ref natus complaint#(b)(4).04 nov 2022 - customer contacted- no response 15 nov 2022 - customer contacted- no response further investigation to be carried out.
Event or Problem Description
Part 8-04-13932 natus medical accuscreen abr/dp type 1077 - false screening results.Reported incident in which false negative screening results were received from testing an infant who, upon further investigation, was in fact found to have a hearing impediment.
Event or Problem Description
Part 8-04-13932 natus medical accuscreen abr/dp type 1077 - false screening results.Reported incident in which false negative screening results were received from testing an infant who, upon further investigation, was in fact found to have a hearing impediment.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint#(b)(4).27 oct 2022 - additional information received detailing the serial number and the customer of the device.Child passed hearing test as false negative.Additional tests after this.Child passed hearing test at 2 years old.Date of incident : (b)(6) 2021.Device has no record of calibration since install date in (b)(6) 2019.Device has never been received for examination since date of incident (b)(6) 2021.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.Complaints are reviewed routinely per quality system requirements (qms-004442 corporate trending and analysis procedure) complaint trends are assessed as part of these reviews.A review of complaint trending is completed quarterly.Last review doc- 060538.No trend for this failure identified the current risk file doc-053250 - 1077 accuscreen & alpha - risk analysis rev05 hazard id 5.45 identifies this issue harm - delay in use of the system or treatment.Cause- "incorrect pass refer result ~ accepted failure rate defined by the algorithms.Incorrect measurements leading to additional patient examination." severity- negligible (0).Risk level- minor (0).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.Device has no record of repair since install date in (b)(6) 2019.Install date: (b)(6) 2019.Further investigation to be carried out.
Additional Manufacturer Narrative
Follow up report 003 ref natus (b)(4).04 nov 22 - customer contacted- no response.15 nov 22 - customer contacted- no response.10 jan 23 - customer contacted - no response.Complaint could not be verified, the device was not returned for evaluation.This case has been closed out.No response from the customer after various attempts.Should the customer decide to send the device at a later stage a new case will be opened by natus.
Event or Problem Description
Part 8-04-13932 natus medical accuscreen abr/dp type 1077 - false screening results.Reported incident in which false negative screening results were received from testing an infant who, upon further investigation, was in fact found to have a hearing impediment.

• Brand Name: ACCUSCREEN ABR/DP TYPE 1077
• Common Device Name: ACCUSCREEN ABR/DP TYPE 1077
• Manufacturer (Section D): NATUS MEDICAL DENMARK APS; hoerskaetten 9; taastrup 2630, ; DA
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park,; gort; galway h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; hoerskaetten 9; taastrup 2630, ; DA
• MDR Report Key: 15672185
• Report Number: 9612197-2022-00009
• Device Sequence Number: 12372976
• Product Code: GWJ
• UDI-Device Identifier: 05713315003974
• UDI-Public: 05713315003974
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/24/2023

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: 8-04-13932
• Device Catalogue Number: 8-04-13932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 10/20/2022; 10/20/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 11/03/2022; 12/01/2022; 02/24/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 2 YR
• Patient Sex: Unknown