inforMED
MalfunctionEFS

PHILIPS SONICARE

Received Feb 3, 2020 · Event occurred Jan 28, 2020

Report 3026630-2020-00009 · MDR key 9661914

Device

Generic name

Airfloss Pro

Model number

HX8340

Catalog number

HX8331/11

Product problems

  • Temperature Problem
  • Temperature Problem

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

THE EVENT DATE IS APPROXIMATE. REPORT SOURCE: COMPLAINT RECEIVED FROM (B)(6).

Description of Event or Problem

A CONSUMER REPORTED THAT THEIR SONICARE AIRFLOSS EXPLODED WHILE CHARGING. NO INJURY OR PROPERTY DAMAGE WAS REPORTED.

Additional Manufacturer Narrative

D4: REVISED LOT # FROM NOT APPLICABLE (NA) TO NO INFORMATION (NI). ANALYSIS RESULTS: THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE DETERMINED AS THE DEVICE OPERATES WITHIN SPECIFICATION.