MAUDE Adverse Event Report: WSAUD A/S WIDEX; WPC101 CHARGE N CLEAN SRIC

Catalog Number	8 936 0300 094
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We were made aware that our electronic submissions failed and were not received by fda.A capa was opened to address this issue and this report is being electronically resubmitted to correct the error of the first failed submission (submitted on 01/10/2024).Distributor, importer and manufacturer are under the ws audiology compliance system.
Event or Problem Description
In this event, the patient's hearing aids and charger melted while charging.Investigation results: charger with accessories and hearing aids were returned for investigation.No sign of melted or burnt part on the external area of the charger.Power adapter and cable connector have no visual defect and no sign of burnt/ melted part.Power adapter has good voltage output but is not a wsa product.Safety information in user guide, instructs user to only use a widex power adapter and cable with charger.Cannot diagnose hearing aids as both are already stuck inside the charging wells, with some parts melted.One of the hearing aid's battery already exploded.Internal components of the charger has signs of melting/burning.2nd level investigation to be performed to determine what went wrong in the charger's internal components.
Event or Problem Description
Results of additional investigation: returned device was disassembled when arrived.Investigation (x-ray and microscope imaging) indicates that heat damage was observed on the driver board near the two flex coil connectors and the usb receptacle.Investigation could not determine if the root cause originated from the hearing aids or the charger, due to the severe damage done to the device.

• Brand Name: WIDEX
• Common Device Name: WPC101 CHARGE N CLEAN SRIC
• Manufacturer (Section D): WSAUD A/S; nymoellevej 6; lynge, DK-35 40; DA DK-3540
• Manufacturer Contact: la-shaunda joseph ; 185 commerce dr.; hauppauge, NY 11788 ; 5617859321
• MDR Report Key: 18961878
• Report Number: 0008021514-2024-00031
• Device Sequence Number: 7051285
• Product Code: OSM
• UDI-Device Identifier: 05706069870510
• UDI-Public: 05706069870510
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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 Catalogue Number: 8 936 0300 094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown