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

Model Number CBA2001

Device Problem Temperature Problem (3022)

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

Event Date 03/30/2022

Event Type  malfunction  

Event Description

Customer reported their diamondclean smart charger exploded and burnt.Visible flames were observed by the customer and their counter top was damaged.No serious injury reported.

Manufacturer Narrative

The event date is approximate.Customer mailing address was not provided.

Manufacturer Narrative

Analysis results: product was not returned to confirm a malfunction has occurred.H3 other text : product not returned to manufacturer.

• Brand Name: PHILIPS SONICARE
• Type of Device: DIAMONDCLEAN 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: chieu yeung ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 14145965
• MDR Text Key: 289775554
• Report Number: 3026630-2022-00041
• 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

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CBA2001
• Device Catalogue Number: HX9903/11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2018
• 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