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

Model Number CBA1001

Device Problem Excessive Heating (4030)

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

Event Date 02/17/2024

Event Type  malfunction  

Event Description

A consumer reported that the charging base was heating up and making smoke.Their granite table was disolored and burned.

Manufacturer Narrative

The event date is approximate.Product was not returned to confirm a malfunction has occurred.

• Brand Name: PHILIPS SONICARE
• Type of Device: DIAMOND CLEAN SMART 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: 18788512
• MDR Text Key: 336332690
• Report Number: 3026630-2024-00012
• 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

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 Model Number: CBA1001
• Device Catalogue Number: HX9924/01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2018
• 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