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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® SNUGGLE WARM® BLANKETS SYSTEM, THERMAL REGULATING

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SMITHS MEDICAL ASD, INC. LEVEL 1® SNUGGLE WARM® BLANKETS SYSTEM, THERMAL REGULATING Back to Search Results
Device Problems Hole In Material (1293); Device Operates Differently Than Expected (2913); Temperature Problem (3022)
Patient Problems Burn(s) (1757); Erythema (1840)
Event Date 02/22/2017
Event Type  Injury  
Manufacturer Narrative
Smiths medical received one snuggle warm® blanket for analysis in a used condition. Upon visual examination two holes were noted to the middle section of the blanket. Quality inspections were performed in 2 hour intervals, burst tests, 4 hour performance tests and internal pressure tests were completed. Relevant documents were reviewed and deemed adequate. The samples were acceptable with no discrepancies noted. Manufacturing process was conducted to verify that there were no non-conformances. A review of the instructions for use (ifu) was performed; warnings were noted upon review that the blanket is just the air distribution device and the connective warmer generates the heat. Functional testing was performed on a sample that was taken from production and connected to an equator. The sample demonstrated good performance. No root cause was found due to the complaint not being confirmed.
 
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
It was reported that during patient use of the snuggle warm® blanket the patient experienced burns and erythema on the left arm. According to the report, the blanket was in use with an equator® convective warming device and the warming device continued to warm "while the temperature had reached 45° celsius". The reported redness on the patient was observed after an "intervention" that lasted one hour and thirty minutes. The patient received an application of biafine cream on the redness and the site was monitored for twenty-four hours; no redness was observed after. The programed temperature of the warming device has been requested; however, it is currently unknown. No permanent damage was reported. Related mfr #'s: 3012307300-2017-00957 and 3012307300-2017-00958.
 
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Brand NameLEVEL 1® SNUGGLE WARM® BLANKETS
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana, b.c 22425
MX 22425
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6523374
MDR Text Key108412795
Report Number3012307300-2017-00914
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/11/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/26/2017 Patient Sequence Number: 1
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