MAUDE Adverse Event Report: GN HEARING A/S GN RESOUND; VO588-DW,VERSO 5

Model Number	VO588-DW,VERSO 5,GN RESOUND
Medical Device Problem Codes	Device Difficult to Maintain (3134); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Skin Irritation (2076); Partial Hearing Loss (4472)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We will not be able to finalize investigation in time for the 30 day time limit, why this is an initial report.
Event or Problem Description
As reported by the local hearing aid dealer: aid has extremely loud static, client cannot wear aid.Happened in patient's home.A loud streaking static sound.Loud streaking static sound coming from aid.Painful to patient.But she took aid off right away.We will not be able to finalize investigation in time for the 30 day time limit, why this is an initial report.
Event or Problem Description
As reported by the local hearing aid dealer: aid has extremely loud static, client cannot wear aid.Happened in patient's home.A loud streaking static sound.Loud streaking static sound coming from aid.Painful to patient.But she took aid off right away.We have previously sent an initial report, why this is the final report.
Additional Manufacturer Narrative
Based on the clinical evaluation below this case has been evaluated not to be reportable and will be downgraded to a normal complaint.There is no serious injury and the tested malfunction is not likely to cause or contribute should it recur.The case has been reviewed from a clinical perspective.Customer reported: the hearing aid had a loud static sound.The end user could not wear it.The sound was reported painful, but hearing aid was taken out immediately.Ea investigation results: the static noise is caused by a faulty front microphone.This is amplified according to prescribed gain.The resulting output does not exceed 100 db spl (measured in 2cc) in any of the programs.Clinical evaluation: the clinical evaluation for the device family does evaluate loud sounds and this is addressed in the risk analysis and mitigated to an acceptable limit by built-in protective measures in the device design.Ea investigation shows that the static noise is a result of a faulty front microphone, but that the resulting output does not exceed 100 db spl.Clinical conclusion on the case is that even though unpleasant, it is evaluated unlikely that shorter exposure of this output level would cause harm to residual hearing.

• Brand Name: GN RESOUND
• Common Device Name: VO588-DW,VERSO 5
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, copenhagen 2750 ; DA 2750
• MDR Report Key: 10501077
• Report Number: 3005650109-2020-00032
• Device Sequence Number: 14142547
• Product Code: OSM
• UDI-Device Identifier: 05704819233226
• UDI-Public: 05704819233226
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: VO588-DW,VERSO 5,GN RESOUND
• Device Catalogue Number: 18741402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention