MAUDE Adverse Event Report: SONOVA AG PHONAK CHARGER CASE GO

Model Number	075301711
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The charger has been requested to be returned for analysis.
Event or Problem Description
Patient reported to hcp that she left a hearing aid charging case on a night stand while she was away from home on a trip.When she returned home, the charger "melted and damaged her bed sheets as they were touching the cord.The charger has been requested to be returned for analysis.Supplemental reports will be submitted upon availability of further information.
Additional Manufacturer Narrative
14.12.2023 no service history has been recorded against the item serial number prior to this report.The charger has not been returned to manufacturers attention, therefore the further investigation could not be performed.This is the final report.

• Brand Name: PHONAK CHARGER CASE GO
• Common Device Name: CHARGER CASE GO
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich, che 8712 ; SZ 8712
• Manufacturer Contact: minal maurya ; 750 n commons dr.; aurora, IL 60504 ; 6308219589
• MDR Report Key: 17588100
• Report Number: 3005085999-2023-00010
• Device Sequence Number: 6353937
• Product Code: OSM
• UDI-Device Identifier: 07613389329995
• UDI-Public: 07613389329995
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/27/2023

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: 075301711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (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: Unknown