MAUDE Adverse Event Report: GN HEARING A/S GN RESOUND; HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY.

Model Number	20967277
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref: # (b)(4).Preliminary investigation concluded that both units had been passed through the test prior to shipment and no abnormality captured throughout the process.Both units were manufactured on 21.07.2021 via dhr wo21704318 (2 years ago).Clinical assessment conclusion: it is reported that 'patients battery doors will not stay closed'.This concerns bte (behind the ear) devices and therefore the risk of foreign body in the ear is not applicable.Due to the missing part, the battery door for the hearing aid will not stay closed and the device will not function.Clinical conclusion of the case is there was no potential patient harm.The user guide includes a warning stating - instrument usage by children or mentally challenged persons should be always supervised to ensure their safety.The hearing instrument contains small parts that could be swallowed by children.Please be mindful not to leave children unsupervised with this hearing instrument'.The user guide also includes a recommendation to immediately seek medical attention if it is swallowed.Additionally, the user guide states if a hearing aid is broken, do not use it.Clinical evaluation according to 0378040 clin eval plan&rpt, ha&tsg: hearing aid powering is a precondition for the hearing aid to function.The risks associated with powering and batteries are reduced as far as possible and the benefit of a hearing aid outweighs these risks.Device has not been received for investigation.This is an initial report.
Event or Problem Description
It is reported that the patients battery doors will not stay closed.This is an initial report.
Event or Problem Description
It is reported that the patients battery doors will not stay closed.No further information has been reported regarding the event.This is a final report.
Additional Manufacturer Narrative
Manufacturer's ref: #(b)(4).Preliminary investigation concluded that both units had been passed through the test prior to shipment and no abnormality captured throughout the process.Both units were manufactured on (b)(6) 2021 via dhr wo21704318 (2 years ago).It has been found that the battery door is week and needs thorough investigation.The device investigation is still to be finalised.Clinical assessment conclusion it is reported that 'patients battery doors will not stay closed'.This concerns bte (behind the ear) devices and therefore the risk of foreign body in the ear is not applicable.Due to the missing part, the battery door for the hearing aid will not stay closed and the device will not function.Clinical conclusion of the case is there was no potential patient harm.The user guide includes a warning stating - instrument usage by children or mentally challenged persons should be always supervised to ensure their safety.The hearing instrument contains small parts that could be swallowed by children.Please be mindful not to leave children unsupervised with this hearing instrument'.The user guide also includes a recommendation to immediately seek medical attention if it is swallowed.Additionally, the user guide states if a hearing aid is broken, do not use it.Clinical evaluation according to 0378040 clin eval plan&rpt,ha&tsg: hearing aid powering is a precondition for the hearing aid to function.The risks associated with powering and batteries are reduced as far as possible and the benefit of a hearing aid outweighs these risks.Risk assessment: known risk.Mitigated.Risk deemed acceptable.This is a follow up report.A final report will be submitted once the invstigations are finalized.The case is late and a nc-02241 has been filed for this error.(b)(6) 2023: follow up: device investigation revealed that the root cause of this case is that the battery click is out of specs.By checking the devices, it is not clear if this out of spec happens because of part manufacture or by misuse.Corrections: the componet code has been changed from battery to locking mechanism.This is a final report.This case is considered as a single incident and will be included in regular trending.No actions have been initiated based on this individual event.
Additional Manufacturer Narrative
Manufacturer's ref: #(b)(4).Preliminary investigation concluded that both units had been passed through the test prior to shipment and no abnormality captured throughout the process.Both units were manufactured on 21.07.2021 via dhr (b)(4) (2 years ago).It has been found that the battery door is week and needs thorough investigation.The device investigation is still to be finalised.Clinical assessment conclusion it is reported that 'patients battery doors will not stay closed'.This concerns bte (behind the ear) devices and therefore the risk of foreign body in the ear is not applicable.Due to the missing part, the battery door for the hearing aid will not stay closed and the device will not function.Clinical conclusion of the case is there was no potential patient harm.The user guide includes a warning stating - instrument usage by children or mentally challenged persons should be always supervised to ensure their safety.The hearing instrument contains small parts that could be swallowed by children.Please be mindful not to leave children unsupervised with this hearing instrument'.The user guide also includes a recommendation to immediately seek medical attention if it is swallowed.Additionally, the user guide states if a hearing aid is broken, do not use it.Clinical evaluation according to (b)(4) clin eval plan&rpt,ha&tsg: hearing aid powering is a precondition for the hearing aid to function.The risks associated with powering and batteries are reduced as far as possible and the benefit of a hearing aid outweighs these risks.Risk assessment: known risk.Mitigated.Risk deemed acceptable.This is a follow up report.A final report will be submitted once the invstigations are finalized.The case is late and a nc-02241 has been filed for this error.
Event or Problem Description
It is reported that the patients battery doors will not stay closed.This is a follow up report.

• Brand Name: GN RESOUND
• Common Device Name: HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY.
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup 2750 ; DA 2750
• Manufacturer Contact: karen frisk ; lautrupbjerg 7; ballerup 2750 ; DA 2750
• MDR Report Key: 16775430
• Report Number: 3005650109-2023-00050
• Device Sequence Number: 20549990
• Product Code: OSM
• UDI-Device Identifier: 05708296156856
• UDI-Public: 05708296156856
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2023

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: Lay User/Patient
• Device Model Number: 20967277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 03/23/2023; 03/23/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 06/20/2023; 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Male