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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL1® EQUATOR® CONVECTIVE WARMING DEVICE SYSTEM, THERMAL REGULATING

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SMITHS MEDICAL ASD, INC. LEVEL1® EQUATOR® CONVECTIVE WARMING DEVICE SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 5000
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Burn, Thermal (2530)
Event Date 05/01/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6). Please see mfr # 3012307300-2018-02253 for related device incident.
 
Event Description
It was reported that a patient was burned on his arm after use of a convective warming system and body blanket. The system was set at 44°c during intervention (duration not available). No additional patient details were provided.
 
Manufacturer Narrative
Correction: (reported burn to the patient with no indication of degree of burn nor was there reported intervention. The event does not meet the definition of a reportable serious injury as (1) the event was not life- threatening; the event did not result in the permanent impairment of a body function or structure; and no intervention was required to preclude serious impairment of a body structure or function. However, the hazardous situation for the given complaint device would likely cause or contribute to a death or serious injury if the malfunction were to recur. ).
 
Manufacturer Narrative
One level one equator blower was received in used condition with a power cord, but no hose or warming blanket were returned with the product. Upon incoming inspection, it was observed the green outer covering on the power on membrane switch was missing and exposing the material underneath. However, this did not affect device performance. Display accuracy was checked and verified with three different settings. Over temperature and occlusion tests were performed and the device appeared to be operating as intended and all temperature readings were within appropriate tolerance. In addition, all relevant documents for the swu warming blanket, listed as a concomitant on the report, were reviewed and deemed adequate and correct with respect to investigation activities. Based on the evidence and testing, the reported problem was not confirmed.
 
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Brand NameLEVEL1® EQUATOR® CONVECTIVE WARMING DEVICE
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7598268
MDR Text Key110965043
Report Number3012307300-2018-02254
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K011907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5000
Device Catalogue NumberEQ-5000-FR-230V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/20/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/13/2018 Patient Sequence Number: 1
Treatment
HOSE FOR LEVEL 1 CONVECTIVE WARMER; LEVEL1 SNUGGLE WARM PATIENT WARMING BLANKET; LEVEL1® SNUGGLE WARM® PATIENT WARMING BLANKET
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