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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 055
Device Problem Fire (1245)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2014
Event Type  malfunction  
Event Description
Flame came out of the switch.A blanket had a black spot on it.
 
Manufacturer Narrative
Our inspection found a small cut in the cord near the switch that could have exposed the user to bare wire.Cord breakage usually occurs when the cord is repeatedly over bent near the switch.We have initiated a capa project (b)(4) to reduce the occurrence of this issue.A new jacketed cord design was launched in production on 3/10/2014 that closes (b)(4) pending a future evaluation of the effectiveness of the solution.
 
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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 Key3784576
MDR Text Key15362456
Report Number1811605-2014-00071
Device Sequence Number1
Product Code IRT
Combination Product (y/n)N
Reporter Country CodeUS
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 03/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number055
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/17/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received03/17/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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