FDA Adverse Event Summary report: N

WARMETTE

MDR report key: 16995 · Received July 7, 1994

Report

Report Number
MW4000522
Date Received
July 7, 1994
Report Date
July 7, 1994
Manufacturer
OLYMPIC MEDICAL CORP.
Product Code
DWJ
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

WHENEVER SOME AMOUNT OF WEIGHT IS PLACED ON PERFORATED WARMING SHELF, THE SHELF BENDS/BOWS. WHEN SHELF IS PRESSED DOWN, IT COMES INTO CONTACT WITH THERMOSTAT THAT IS LOCATED UNDER THE SHELF. THE THERMOSTAT TOUCHES THE BOTTOM OF THE METAL WHERE THE MAIN HEATING ELEMENT IS LOCATED, CUTTING OFF THE HEAT. THE WIRES OF THE THERMOSTAT TOUCH THE HOT METAL FLOOR WHERE IT COULD MELT AND LEAD TO A SHOCK/FIRE HAZARD. UNIT TAKEN OUT OF SERVICE, UNTIL BIOMEDICAL ENGINEERING CAN DISCUSS/RESOLVE PROBLEM WITH MFR. MFR RESPONSE AS FOLLOWS. SHOCK HAZARD: THE INCIDENT DESCRIBED DOES NOT PRESENT A SHOCK HAZARD TO THE OPERATOR. THIS DEVICE IS FUSE PROTECTED (SCHEMATIC ENCLOSED), AND A FAILURE, AS DESCRIBED IN THE REPORT, CAUSES A SHORT CIRCUIT, OPENING THE FUSE AND IMMEDIATELY INTERRUPTING POWER TO THE UNIT. FLAMMABILITY: THIS DEVICE IS DESIGNED WITH A METAL SHIELD ISOLATING THE HEATING ELEMENT, AND THE TEMPERTURE OF THIS METAL SHIELD CANNOT EXCEED, EVEN AT CONTINUOUS MAXIMUM TEMPERATURE OPERATION, THE IGNITION TEMPERATURE OF BLANKETS AND ANY OTHER MATERIAL DESCRIBED IN THE DEVICE'S INTENDED USE. THIS DEVICE IS ALSO CSA APPROVED, WHICH INCLUDES A FLAMMABILITY TEST OF THE WARMER OPERATING AT MAXIMUM TEMPERATURE FOR SEVEN HOURS WRAPPED IN FLAMMABLE MATERIALS. A NEW SHIELDED THERMOSTAT CONFIGURATION WAS DESIGNED AND A RETRO KIT FOR THE THERMOSTAT WAS FURNISHED TO THE HOSP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 WARMETTE BLANKET WARMER DWJ OLYMPIC MEDICAL CORP. 56910

Patients

Seq Age Sex Outcome Treatment
1 *