MAUDE Adverse Event Report: SONOVA AG PHONAK MINI CHARGER CASE

Model Number 075-3009

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A hearing aid charger overheated and caused a superficial damage to cover material of the patient's couch.The device has initially been sent for repair in september and discarded as no associated complaint has been raised.The customer received a replacement at the time.No injury to patient or other parties has been reported.The case is being reported due to a damage to patient's property.The device is not available for analysis, therefore no technical investigation will be conducted.This is the final report.

Manufacturer Narrative

Device is discarded.Therefore, device analysis is not available for analysis.

• Brand Name: PHONAK MINI CHARGER CASE
• Type of Device: PHONAK MINI CHARGER CASE
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich,che 8712 ; SZ 8712
• Manufacturer Contact: minal maurya ; 750 n commons dr.; aurora, IL ; 6308219589
• MDR Report Key: 18283369
• MDR Text Key: 329948062
• Report Number: 3005085999-2023-00014
• Device Sequence Number: 1
• Product Code: OSM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 075-3009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other