MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; SONICARE CHARGER

Catalog Number HX3681/03

Device Problem Excessive Heating (4030)

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

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

The event date is approximate.Product was not returned to confirm a malfunction has occurred.H3 other text : device not returned.

Event Description

The customer reported to philips that the charger had a burnt smell and the charger was burnt.There was property damage.There was no patient harm reported.

Manufacturer Narrative

The consumer reported: "burnt smell, burnt charger & damage property" one toothbrush was returned to ohc for failure analysis with one charger arriving in used condition.The device was sent to finished good supplier, donlim for further analysis.Per the failure analysis, it was observed that the issue was burnt charger.The failure analysis concluded that the charger is functional and able to charge the returned toothbrush, and the cause of the burnt is due to external heat source.

• Brand Name: PHILIPS SONICARE
• Type of Device: SONICARE CHARGER
• Manufacturer (Section D): PHILIPS ORAL HEALTHCARE, LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ORAL HEALTHCARE, LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: ellen patterson ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 17703129
• MDR Text Key: 322887909
• Report Number: 3026630-2023-00064
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: HX3681/03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1