inforMED
MalfunctionIRT

THERMOPHORE

Received Mar 6, 2020

Report 1832415-2020-11159 · MDR key 9801822

Device

Generic name

Thermophore

Model number

155

Lot number

00155044182

Product problems

  • Failure to Shut Off

Patient

Not reported

  • Injury
  • Injury

Narrative

Description of Event or Problem

CUSTOMER STATED, "UNIT WILL NOT SHUT OFF". CUSTOMER DID NOT CLAIM INJURY. PRODUCT WAS RETURNED. THE UNIT WAS TESTED FOR FUNCTION AND WAS DETERMINED TO HAVE NO CONTINUITY IN THE SWITCH. THE LIGHT ON THE SWITCH FUNCTIONED, BUT WOULD NOT TURN OFF. THE SWITCH FUNCTION OF THE UNIT COULD NOT OPERATE AS THERE WAS NO CONTINUITY TO THE PAD. THE DETERMINED CAUSE OF THE MALFUNCTION IS UNKNOWN AND THE SWITCH WILL BE SENT TO THE MANUFACTURER FOR FURTHER INVESTIGATION. ANY ADDITIONAL INFORMATION FROM THE INVESTIGATION WILL BE SUBMITTED WITH A SUPPLEMENTAL REPORT.