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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE AUTOMATIC HEAT PACK; ELECTRIC MOIST HEAT PACK
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BATTLE CREEK EQUIPMENT THERMOPHORE AUTOMATIC HEAT PACK; ELECTRIC MOIST HEAT PACK Back to Search Results
Model Number 195
Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2014
Event Type  malfunction  
Event Description
Customer was laying on pad and it burned her pillow and blanket.
 
Manufacturer Narrative
Our inspection revealed that several internal components designed to restrain the heater wire had been bent or broken.This damage had allowed the loose heater wire to tangle together, creating an area of excessive heat, which had damaged and deteriorated the fabric foundation.The pad was folded over which caused a hot spot in the pad.Lead laying on top of lead and wire.Our inspection also found: cord twisted, pad bunched, bent/broken lead, bent/broken thermostat, thermostat discoloration, pad dirty or stained.Based on the overall condition of the pad, we concluded that the heating pad was not used in accordance with our instructions.
 
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Brand Name
THERMOPHORE AUTOMATIC HEAT PACK
Type of Device
ELECTRIC MOIST HEAT PACK
Manufacturer (Section D)
BATTLE CREEK EQUIPMENT
fremont IN
Manufacturer Contact
randy newsome
702 south reed street
fremont, IN 46737
2699626181
MDR Report Key4390596
MDR Text Key17995979
Report Number1811605-2014-00250
Device Sequence Number1
Product Code IRT
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number195
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received12/09/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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