MAUDE Adverse Event Report: WSAUD A/S. SIGNIA; SIGNIA PORTABLE CHARGER RIC

Model Number	10994013
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/29/2023
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 07/26/2023).Distributor, importer and manufacturer are under the ws audiology compliance system.
Event or Problem Description
In this event, patient was traveling and woke up to the smell of smoke while signia portable charger was plugged in; photos provided show the cable had melted and detached from plugged in charger.Results of technical investigation showed local heat damage near usb receptacle (nothing was observed that would indicate fire); the device enclosure and cable insulation is warped and discolored, consistent with exposure to heat.The usb cable connector was detached from the usb cable and is attached to the usb receptacle, which is consistent with the usb cable being pulled from the device while the usb cable connector was hot.Findings support the suspected root-cause that 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.

• Brand Name: SIGNIA
• Common Device Name: SIGNIA PORTABLE CHARGER RIC
• Manufacturer (Section D): WSAUD A/S.; nymoellevej 6; lynge, DK-35 40; DA DK-3540
• Manufacturer Contact: la-shaunda joseph ; 101 wood avenue south; 7th floor; iselin, NJ 08830 ; 5617859321
• MDR Report Key: 18912974
• Report Number: 0008021514-2024-00024
• Device Sequence Number: 12485851
• Product Code: OSM
• UDI-Device Identifier: 05714880114867
• UDI-Public: 05714880114867
• 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): 03/15/2024

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 Model Number: 10994013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• 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