FDA Adverse Event Summary report: N

THERMOPHORE

MDR report key: 40047 · Received September 10, 1996

Report

Report Number
1811605-1996-09011
Date Received
September 10, 1996
Report Date
September 10, 1996
Manufacturer
BATTLE CREEK EQUIPMENT CO
Product Code
IRT
Report Source
Manufacturer report
Reporter Location
VA, US
Reporter Occupation
NO INFORMATION

Narratives

Description of Event or Problem · 1

THE SWITCH EMITTED SMOKE AND THE USER REC'D A MINOR SHOCK. CO'S INSPECTION REVEALED CARBON DEPOSITS WERE PRESENT IN THE SWITCH. NO DEATHS OR INJURIES WERE REPORTED. FROM APPROX 1967 TO JUNE 21, 1990, CO USED A SWITCH MANUFACTURED BY A REPUTABLE FIRM. THE SWITCH WAS A MOMENTARY TYPE SWITCH WITH A SPRING LOADED LEVER WHICH REQUIRED BEING HELD IN THE "ON" POSITION TO MAKE CONTACT. SOMETIMES A USER WOULD NOT FULLY ENGAGE THE LEVER, ALLOWING THE CONTACTS TO REMAIN SLIGHTLY OPEN WHICH COULD INDUCE ARCING. WHEN CONSISTENTLY HELD IN THIS WAY, CARBON BUILD-UP FROM THE ARCING COULD REACH OPPOSITE POLES CAUSING THE SWITCH TO EMIT A SMALL AMOUNT OF SMOKE. CO'S FIRST SOLUTION WAS TO CHANGE THE CONTACT MATERIAL AND THE BODY OF THE SWITCH BODY. ALTHOUGH THE SITUATION WAS IMPROVED, THE OCCASIONAL RELEASE OF A PUFF OF SMOKE WAS POSSIBLE. ON 6/21/90, CO BEGAN USING A SNAP ACTION SWITCH WHICH. DOES NOT ALLOW THE CONTACTS TO BE HELD IN A SLIGHTLY OPEN POSITION. THIS EVENT IS NOT REPORTABLE UNDER 21CFR803 BECAUSE SIMILAR EVENTS WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS BEING MADE TO BE COMPLIANT WITH REGULATORY LETTER 90-DT-12. REMEDIAL ACTION HAS BEEN ACCOMPLISHED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 THERMOPHORE HEATING PAD IRT BATTLE CREEK EQUIPMENT CO 055 NONE

Patients

Seq Age Sex Outcome Treatment
1 *