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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SNUGGLE WARM PEDIATRIC CONVECTIVE WARMING BLANKET SYSTEM, THERMAL REGULATING

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SMITHS MEDICAL ASD, INC. SNUGGLE WARM PEDIATRIC CONVECTIVE WARMING BLANKET SYSTEM, THERMAL REGULATING Back to Search Results
Model Number SWU-2009
Device Problem Malposition of Device (2616)
Patient Problems Rash (2033); Burn, Thermal (2530); No Code Available (3191)
Event Date 10/01/2018
Event Type  Injury  
Manufacturer Narrative
Foreign : (b)(6). (b)(4). Thermal burn was another patient code used as there was no information to confirm what level of degree burn the patient received (e. G. Second degree burn).
 
Event Description
Information was received that a smiths medical snuggle warm pediatric convective warming blanket was used for approximately five and a half hours on an infant during cardiac surgery. Initially, the product was disinfected with chlorhexidine and was set to 40 degrees celsius for the first one and a half hours of use. The patient was positioned above the blanket during the operation, and their buttocks were laid on the portion of the blanket where a shoulder should be applied to. The next two hours, the product was used with the blowing setting (room air reported to be about 22 degrees). Extracorporeal circulation was conducted using an artificial cardiopulmonary apparatus and air was kept ventilated. The patient was monitored by rectal, skin, and pharyngeal temperature measurements. It was noted at an unspecified time that the rectal temperature felt "higher than usual". For the remaining two hours of use, while the patient recovered from anesthesia, the blanket was warmed up to 36 degrees celsius. It was then discovered after the operation that the patient sustained five to six red rashes (sized eight to ten mm) at the sides of the infant's buttocks. The following day, it was reported the rashes developed into blisters. It was also reported the "patient was treated for burn," but detail regarding the medical treatment and outcome is unknown. No additional adverse patient effects were reported.
 
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Brand NameSNUGGLE WARM PEDIATRIC CONVECTIVE WARMING BLANKET
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key8097655
MDR Text Key128184790
Report Number3012307300-2018-08380
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K141686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberSWU-2009
Device Catalogue NumberSWU-2009
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2018
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

Patient Treatment Data
Date Received: 11/21/2018 Patient Sequence Number: 1
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