inforMED
MalfunctionEFS

PHILIPS SONICARE

Received Jun 6, 2024 · Event occurred May 13, 2024

Report 3026630-2024-00040 · MDR key 19478046

Device

Generic name

Tsangpo Power Flosser

Model number

HX386W

Catalog number

HX3804/21

Product problems

  • Overheating of Device
  • Overheating of Device

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE EVENT DATE IS APPROXIMATE. PRODUCT WAS NOT RETURNED TO CONFIRM A MALFUNCTION HAS OCCURRED.

Description of Event or Problem

THE CONSUMER REPORTED THAT THE TSANGPO POWER FLOSSER CAUGHT ON FIRE. THERE WERE NO REPORTS OF INJURY OR PROPERTY DAMAGE.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED NOR REQUIRED FOR INVESTIGATION. THE ROOT CAUSE HAS BEEN ADDRESSED AND EXECUTED THROUGH DESIGN CHANGE. THIS IS A KNOWN ISSUE WHICH HAS BEEN ADDRESSED BY PH OHC DESIGN CHANGE AND IMPLEMENTED.

Description of Event or Problem

THE DEVICE WAS NOT RETURNED NOR REQUIRED FOR INVESTIGATION. THE ROOT CAUSE HAS BEEN ADDRESSED AND EXECUTED THROUGH DESIGN CHANGE. THIS IS A KNOWN ISSUE WHICH HAS BEEN ADDRESSED BY PH OHC DESIGN CHANGE AND IMPLEMENTED.