MAUDE Adverse Event Report: WSAUD A/S WIDEX; MRIC CHARGER WPT102

Catalog Number	8 936 0500
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
In this event, health care professional had informed that a patient's charger was damaged and usb entrance was burnt, while charging.Investigation results: burnt marks found on the charger and connector; the micro-usb was left on the receptable.X-ray result shows no abnormality inside the charger that proves burning/ melting started on the connector itself.Since part of the connector is thoroughly burnt, cannot validate if it was induced by cable related defect or by user.The results of the visual inspection and technical assessment indicate that the root-cause is a short circuit developed in the usb connector or usb receptacle due to corrosion, bent pins, or foreign debris.Corrective and preventative actions have now been implemented and documented in a capa.Preventative action was taken to reduce the portable charger's maximum battery capacity from 100% to 80% to prevent extensive battery reactions during battery short-circuit.Preventive measure was verified to be effective in further reducing the possibility and sufficient energy to cause severe melting cases.No further root causes have been identified.
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 (b)(6) 2023).Distributor, importer and manufacturer are under the ws audiology compliance system.

• Brand Name: WIDEX
• Common Device Name: MRIC CHARGER WPT102
• Manufacturer (Section D): WSAUD A/S; nymollevej 6; lynge, 3540D NK; DA 3540DNK
• Manufacturer Contact: la-shaunda joesph ; 185 commerce dr.; hauppague, NY 11788 ; 5617859321
• MDR Report Key: 18968966
• Report Number: 0008021514-2024-00027
• Device Sequence Number: 6807437
• Product Code: OSM
• UDI-Device Identifier: 05714879048043
• UDI-Public: 05714879048043
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 03/25/2024

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 0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 03/25/2024
• 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