FDA Adverse Event Malfunction Summary report: N

THERMOPHORE

MDR report key: 55060 · Received December 4, 1996

Report

Report Number
1811605-1996-09086
Event Type
Malfunction
Date Received
December 4, 1996
Report Date
December 4, 1996
Manufacturer
BATTLE CREEK EQUIPMENT CO.
Product Code
IRT
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
INVALID DATA

Narratives

Description of Event or Problem · 1

THE SWITCH EMITTED SMOKE. INSPECTION REVEALED CARBON DEPOSITS WERE PRESENT IN THE SWITCH. NO DEATHS OR INJURIES WERE REPORTED. FROM APPROX. 1967 TO JUNE 21, 1990 CO USED AN UNDERWRITER'S LABORATORIES LISTED A SWITCH MANUFACTURED BY A REPUTABLE FIRM. THE SWITCH WAS 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. THIS REDUCED THE ARCING OF THE CONTACTS AND THE CARBON TRACKING 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 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 *