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

Model Number	21569800
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Technical investigation concluded: no deviation or changes were found during manufacturing of the device.The returned apollo 5.3 charger is returned because the usb-c connector is broken down the returned device has signs of heating around the usb-c connector, also the cable shows signs of heating.The charger is fully functional except of the connector.It can charge two hearing aids.The internal battery is working.The usb-c connector has broken down mechanical.It is a known problem with usb connectors, that in rare cases wear or dirt/moist can create a low ohmic path from vbus to gnd, that potential can cause a heating inside of the connector.The clinical investigation concluded: the connector is broken, probably because the user has (not intentionally) misused it, while inserting the cable.If the cable has been slightly out of specification that could have had a negative effect on this.This has caused a low ohmic connection in the cable connector - almost a short circuit - that will emit heat when the cable is inserted into the wall charger, causing up to the rated 5 w of the wall charger to be dissipated inside the connector.Micro usb is a very well-known and used standard but can mechanically break down.Based on these results, clinical conclusion on this case is that there is a potential risk of heat dissipation based on the findings, but the breakdown appears to be the results of insertion of usb cable that unintentionally broken down the connector when mating the cable connector to the receptable on the pcb.Clinical evaluation according to 0378080 clin eval plan&rpt,wl acc: from the investigation it is concluded that the high temperatures are limited to places difficult to touch, such as the back of the charger.Clinical conclusion on the case is that, even though unpleasant, it is evaluated unlikely that the device in failure mode would cause harm, if the event were to reoccur, because of the unlikely event of contacting the difficult to touch location.Risk register reference: the residual risk after the risk control measure(s) is acceptable.No new hazardous situations revealed and no need to update the risk register based on the above information the case is considered reportable as the malfunction did lead to, or might led to, death or a serious injury.This is a late report.
Event or Problem Description
The charger caught on fire and melted in the usb port.It happened at home where the patient experienced a smell of hot rubber first, then saw smoke and the spark.The user was quick enough to unplug the charger and remove the hearing aids.No harm was reported and no contact with an authorized medical practioner.Original accessories were used, and rechargeable batteries were used.
Additional Manufacturer Narrative
Technical investigation concluded: no deviation or changes were found during manufacturing of the device.The returned apollo 5.3 charger is returned because the usb-c connector is broken down the returned device has signs of heating around the usb-c connector, also the cable shows signs of heating.The charger is fully functional except of the connector.It can charge two hearing aids.The internal battery is working.The usb-c connector has broken down mechanical.It is a known problem with usb connectors, that in rare cases wear or dirt/moist can create a low ohmic path from vbus to gnd, that potential can cause a heating inside of the connector.The clinical investigation concluded: the connector is broken, probably because the user has (not intentionally) misused it, while inserting the cable.If the cable has been slightly out of specification that could have had a negative effect on this.This has caused a low ohmic connection in the cable connector - almost a short circuit - that will emit heat when the cable is inserted into the wall charger, causing up to the rated 5 w of the wall charger to be dissipated inside the connector.Micro usb is a very well-known and used standard but can mechanically break down.Based on these results, clinical conclusion on this case is that there is a potential risk of heat dissipation based on the findings, but the breakdown appears to be the results of insertion of usb cable that unintentionally broken down the connector when mating the cable connector to the receptable on the pcb.Clinical evaluation according to 0378080 clin eval plan&rpt,wl acc: from the investigation it is concluded that the high temperatures are limited to places difficult to touch, such as the back of the charger.Clinical conclusion on the case is that, even though unpleasant, it is evaluated unlikely that the device in failure mode would cause harm, if the event were to reoccur, because of the unlikely event of contacting the difficult to touch location.Risk register reference: the residual risk after the risk control measure(s) is acceptable.No new hazardous situations revealed and no need to update the risk register based on the above information the case is considered reportable as the malfunction did lead to, or might led to, death or a serious injury.This is a late report.(b)(6) 23 - correction: a review of the information provided identified that although smoke and sparks were observed, no flame or fire was confirmed by patient.The patient reported the burning smell and a spark but were unable to confirm if a flame was visible or not.R&d investigation concluded: the deformation of the outer casing surrounding the usb-c connector is quite minor.No residue accumulation such as soot or smoke accumulation on the charger surfaces was observed.Open fires tend to develop soot and smoke which are moving upward and accumulate on the near visible surfaces.Deformation of the plastic housing is symmetrical - in open fire cases, often asymmetrical deformations depending on fire initiation and progress would be expected o it is concluded that there was no objective evidence of fire.
Event or Problem Description
The charger caught on fire and melted in the usb port.It happened at home where the patient experienced a smell of hot rubber first, then saw smoke and the spark.The user was quick enough to unplug the charger and remove the hearing aids.No harm was reported and no contact with an authorized medical practioner.Original accessories were used, and rechargeable batteries were used.(b)(6) 2023: a review of the information provided identified that although smoke and sparks were observed, no flame or fire was confirmed by the patient.The patient reported the burning smell and a spark but were unable to confirm if a flame was visible or not.

• 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: 15319460
• Report Number: 3005650109-2022-00028
• Device Sequence Number: 20134431
• Product Code: OSM
• UDI-Device Identifier: 05708296200276
• UDI-Public: 05708296200276
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2023

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: 21569800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Male