MAUDE Adverse Event Report: GN HEARING A/S GN RESOUND; RE761-DRWC,LINX QUATTRO 7

Model Number	RE761-DRWC,LINX QUATTRO 7,GN RESOUND
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Codes	Skin Irritation (2076); Superficial (First Degree) Burn (2685)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Comment by manufacturer: 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 local customer service: aid hot to the touch and not holding charge.I have a patient wanting to bring her aids in tomorrow.She has had the quattro 7 since september and now when she removes them one is dead and the other is hot! i told her not to wear them and to bring them in immediately with the charger so i can send them in.Would it be possible for you to send another set overnight? i know they usually don't repair them when this happens.Here are her serial numbers: (b)(4).Questionnaire: did the event and/or device cause harm to the patient, other person(s) or property? no.
Additional Manufacturer Narrative
1.Initial report: comment by manufacturer: we will not be able to finalize investigation in time for the 30 day time limit, why this is an initial report.2.Follow-up/final report: final conclusion based on the investigation is that this case is not reportable and will be downgraded to a normal complaint.The device did not actually burn the user, but it felt very hot.No permanent harm or intervention.No serious injury.A study has proven (agile doc id 0409290) that heat energy generated in the device during use does not reach temperatures high enough to cause any harm to the user/patient or other persons and would not if it recur.It can be perceived as uncomfortably warm however, but can not cause any serious injury.Test of these specific devices has not observed any safety issues.Theres no risk for death or serious injury should it recur.This is considered a single incident and will be included in regular trending.No actions has been initiated based on this individual event.
Event or Problem Description
As reported by local customer service: aid hot to the touch and not holding charge.I have a patient wanting to bring her aids in tomorrow.She has had the quattro 7 since september and now when she removes them one is dead and the other is hot! i told her not to wear them and to bring them in immediately with the charger so i can send them in.Would it be possible for you to send another set overnight? i know they usually don't repair them when this happens.Here are her serial numbers: (b)(6) & (b)(6).Questionnaire: did the event and/or device cause harm to the patient, other person(s) or property? no previously an initial report has been sent - this is the follow-up/final report.

• Brand Name: GN RESOUND
• Common Device Name: RE761-DRWC,LINX QUATTRO 7
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, copenhagen 2750 ; DA 2750
• MDR Report Key: 11075547
• Report Number: 3005650109-2020-00056
• Device Sequence Number: 19515944
• Product Code: OSM
• UDI-Device Identifier: 05708296145447
• UDI-Public: 05708296145447
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/27/2021

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: RE761-DRWC,LINX QUATTRO 7,GN RESOUND
• Device Catalogue Number: 20686220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 01/27/2021
• 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: Disability