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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 Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/07/2014
Event Type  malfunction  
Event Description
Customer stated that smoke came out of the switch.
 
Manufacturer Narrative
Our inspection found a small cut in the cord near the switch that could have exposed the user to bare wire.The inspection also revealed customer misuse as our inspection found: fda: cord cut/burned strain relief, cracked switch case, pad ok.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 03/10/2014 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 st
fremont, IN 46737
2699626181
MDR Report Key3823725
MDR Text Key4400780
Report Number1811605-2014-00104
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 05/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2014
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? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received04/24/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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