inforMED
MalfunctionIRT

THERMOPHORE

Received Mar 18, 2020

Report 1832415-2020-11223 · MDR key 9850766

Device

Generic name

Thermophore

Lot number

003040

Product problems

  • Fire

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, "FLAMES OF FIRE SHOT OUT OF THE SWITCH." CUSTOMER DID NOT CLAIM INJURY. PRODUCT WAS NOT RETURNED. THE PRODUCT REPORTED OF HAVING AN ISSUE IS APPROXIMATELY 63 YEARS OLD. THE CONFIRMATION OF THE FAILURE COULD NOT BE CONFIRMED, AS THE PRODUCT WAS NOT RECEIVED. THE AGE OF THE DEVICE IS THE LIKELY CAUSE OF ANY FAILURES. ONCE PRODUCT IS RECEIVED AND INVESTIGATED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.