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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 RADIANT WARMER; WARMING SYSTEM
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SMITHS MEDICAL ASD, INC. LEVEL 1 RADIANT WARMER; WARMING SYSTEM Back to Search Results
Model Number S1000
Device Problem Device Inoperable (1663)
Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694)
Event Date 01/28/2016
Event Type  Injury  
Event Description
This patient was coming out of surgery, warming blanket was removed, and found to have redness and blisters on left arm and shoulder.Per dermatology note, probable burn, partial thickness, second degree, possibly related to the forced air warming blanket and hose.Patient may be at great risk of injury given thin skin from use of high potency typical steroid for psoriasis.At discharge, wound nurse wrote: left arm blisters are drying, no signs of deep tissue involvement.This device and hose were tested by clinical engineering department post event.The hose had a thermistor malfunction, but the overtemp safety switch was fully functioning as designed (which alarms and shuts down machine when hits max temp allowed).
 
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Brand Name
LEVEL 1 RADIANT WARMER
Type of Device
WARMING SYSTEM
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
dublin OH 43017
MDR Report Key5431183
MDR Text Key38132461
Report NumberMW5060117
Device Sequence Number1
Product Code DWJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/08/2016
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberS1000
Device Catalogue NumberSW5-HOSE-7
Other Device ID NumberCE660
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
Patient Weight100
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