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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL LEVEL 1 CONVECTIVE WARMER SYSTEM, THERMAL REGULATING

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ST PAUL LEVEL 1 CONVECTIVE WARMER SYSTEM, THERMAL REGULATING Back to Search Results
Model Number EQ-5000
Device Problem Excessive Heating (4030)
Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694); Blister (4537)
Event Date 02/15/2022
Event Type  Injury  
Event Description
It was reported that while using the warming device during long surgery on the patient's upper extremities, the patient experienced second degree burns, blisters, and redness on the neck and thorax, chest area, clavicular area, and deltoids. The warming blanket was on 40 c, a standard medium temperature for these procedures. Electro-medicine department at the reporters facility evaluated it and confirmed it works correctly.
 
Manufacturer Narrative
The device was unable to be evaluated as it was not returned. If the device is received in the future an evaluation will be performed. The reported event was unable to be confirmed or replicated. A cause of the reported event could not be determined at this time. A dhr review was unable to be completed as no serial information of the device was provided.
 
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Brand NameLEVEL 1 CONVECTIVE WARMER
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key13826007
MDR Text Key287575009
Report Number3012307300-2022-04724
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K011907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEQ-5000
Device Catalogue NumberEQ-5000
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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