inforMED
MalfunctionIRT

THERMOPHORE

Received Sep 24, 2017

Report 1832415-2017-06691 · MDR key 6889433

Device

Generic name

Thermophore

Model number

255

Lot number

2551014

Product problems

  • Sparking

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

CUSTOMER STATED "SWITCH SPARKED INSIDE." THE PRODUCT WAS NEVER RETURNED FOR INVESTIGATION. BASED ON THE BCE REVIEW OF FEEDBACKS, BCE DID NOT OBSERVE A SIMILAR ISSUE WITHIN THE LOT.