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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG LEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEM SYSTEM, THERMAL REGULATING

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SMITHS HEALTHCARE MFG LEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEM SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number SWU-2113
Device Problem Insufficient Information (3190)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 06/08/2016
Event Type  Injury  
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
This event occured in (b)(4). User facility reported that the device was in use with a patient during a valve plasty surgery for approximately 4 hours. According to reporter, the patient sustained a second degree burn on the leg. Reporter stated the device was in use on the lowest temperature setting (36 degrees c). The patient's burns were treated with paraffin tulles. No permanent adverse effects reported. Unknown patients condition at this time. Please reference mdr#: 2183502-2016-01386 for associated complaint.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Further information was received from the user facility that during the procedure a vesical probe temperature and esophagus intubation equipment were utilized with the equator convective warming device. It was also reported that there were no alarms that went off during the procedure on the device, and the patient was covered except on the scarpas (both parts), thorax and head. During and after the procedure the patient's temperature remained at 36. 4 degrees c, but the patient's temperature was warmed by extracorporal circulation between the temperature of 35. 5 and 37. 3 degree c. It was also reported that the patient did receive intravenous fluids; isofundinz and ringer lactate before and during use of the warming blanket. Additional information was also received on the patient that they didn't have peripheral vascular disease or low cardiac output, and that the patient is having a rapid recovery.
 
Manufacturer Narrative
Correction note: the original aware date was june 9, 2016. (b)(4).
 
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Brand NameLEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEM
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana 55425
MX 55425
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana 55425
MX 55425
Manufacturer Contact
lisa perz
1265 grey fox rd
st. paul, MN 55112
7633833074
MDR Report Key5836293
MDR Text Key50824736
Report Number2183502-2016-01385
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K011907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSWU-2113
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/01/2016 Patient Sequence Number: 1
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