MAUDE Adverse Event Report: NATUS MEDICAL DENMARK 1081 AURICAL AUD WITH HI-PRO (US ONLY) INCL. BONE CONDUCTOR/INSERT PHONE AND TDH

Model Number	8-04-14530
Medical Device Problem Code	Electrostatic Discharge (2149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report (ref natus complaint# (b)(4).Customer reports static shock from the dispenser monitor headset.Customer has been advised to return the device for evaluation.Questionnaire has been sent to service to follow up with the customer- awaiting response.There are no capa's related to this issue.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- 058110.No trend for this failure identified.The current risk file doc-049943 - 1053 aurical freefit - risk analysis rev 04 - hazard id 5.30 identifies this issue harm -delay in use of the system or treatment.Cause- device hit by esd on connectors.Device loses connection.(electrostatic discharge interferes with function or control on device.(esd immunity), causing exposure to loud sound) 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.Installed date (b)(6) 2017 a search for service data that may be relevant to this issue has been conducted.No further information related to this issue found.
Event or Problem Description
Caller reports they felt a static shock from the dispenser monitor headset and now the talk forward portion of the headset is not working.They tried a known working headset in this booth, and it does not work in this booth, only the audio works on the headset, not the microphone part.Both headsets work fully in the other booth.The caller believes that the aurical itself got physically damaged when they felt the static shock.
Additional Manufacturer Narrative
Follow up report 001 (ref natus complaint #(b)(4)) questionnaire returned from the customer and noted the following: the event occurred durning speech test - static shock on cheek (from monitor headset) , talk forward stopped working no patient involvement.No injuries reported all components of the device will be returned to natus for evaluation.
Event or Problem Description
Caller reports they felt a static shock from the dispenser monitor headset and now the talk forward portion of the headset is not working.They tried a known working headset in this booth, and it does not work in this booth, only the audio works on the headset, not the microphone part.Both headsets work fully in the other booth.The caller believes that the aurical itself got physically damaged when they felt the static shock.
Event or Problem Description
Caller reports they felt a static shock from the dispenser monitor headset and now the talk forward portion of the headset is not working.They tried a known working headset in this booth, and it does not work in this booth, only the audio works on the headset, not the microphone part.Both headsets work fully in the other booth.The caller believes that the aurical itself got physically damaged when they felt the static shock.
Additional Manufacturer Narrative
Follow up report 002 (ref natus complaint#1(b)(4)).A dhr 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.Service repair investigations will be conducted during the repair process and trend data will be reviewed per (b)(4).Repair record review: calibration of one booth.Facing the booths , calibrate the right booth under service case (b)(4) on 15 mar 2021.All components of the device to be returned to natus for evaluation.
Additional Manufacturer Narrative
Follow up report 003 (ref natus complaint#(b)(4).The affected device was returned.Investigation result code:taastrup|headset.Failure confirmed: yes.Based on the engineering input - it is expected behaviour - "electrostatic discharge interferes with function or control on device' (ref doc-049943 rev 04 - 1053 aurical freefit risk analysis hazard id 5.30) closure rationale: complaint verified, expected behavior.
Event or Problem Description
Caller reports they felt a static shock from the dispenser monitor headset and now the talk forward portion of the headset is not working.They tried a known working headset in this booth, and it does not work in this booth, only the audio works on the headset, not the microphone part.Both headsets work fully in the other booth.The caller believes that the aurical itself got physically damaged when they felt the static shock.

• Brand Name: 1081 AURICAL AUD WITH HI-PRO (US ONLY) INCL. BONE CONDUCTOR/INSERT PHONE AND TDH
• Common Device Name: 1081 AURICAL AUD WITH HI-PRO (US ONLY) INCL. BONE CONDUCTOR/INSERT PHONE AND TDH
• Manufacturer (Section D): NATUS MEDICAL DENMARK; 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: 13787420
• Report Number: 9612197-2022-00004
• Device Sequence Number: 12034335
• Product Code: EWO
• UDI-Device Identifier: 05713315004049
• UDI-Public: 05713315004049
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 11/07/2022
• 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
• Operator of Device: Health Professional
• Device Model Number: 8-04-14530
• Device Catalogue Number: 8-04-14530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 03/10/2022; 03/10/2022; 03/10/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 06/10/2022; 07/04/2022; 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2017
• 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