MAUDE Adverse Event Report: PHILIPS SONICARE; DIAMONDCLEAN SMART CHARGER

Model Number CBA2001

Device Problem Temperature Problem (3022)

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

Event Date 07/26/2021

Event Type  Injury  

Manufacturer Narrative

The event date is approximate.The complaint was received from a consumer in (b)(6).

Event Description

A consumer reported that their diamondclean smart charger glass exploded.No injury or property damage was reported.

Manufacturer Narrative

D4: device serial number was identified and updated during analysis.H4: device manufacture date was identified and updated during analysis.Analysis results - the root cause of the customer¿s complaint was a burned charger.

• Brand Name: PHILIPS SONICARE
• Type of Device: DIAMONDCLEAN SMART CHARGER
• MDR Report Key: 12242775
• MDR Text Key: 264053996
• Report Number: 3026630-2021-10027
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• 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: HX9903/13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Distributor Facility Aware Date: 07/26/2021
• Date Manufacturer Received: 08/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2017
• 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