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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE SYSTEM, THERMAL REGULATING

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SMITHS MEDICAL ASD INC. LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number CON-EQ-5000
Device Problem Insufficient Information (3190)
Patient Problem Burn(s) (1757)
Event Type  malfunction  
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
The customer reported that the hose was missing the air diffuser on the equator® convective warmer that resulted in a light burn to the inner thigh. Additional information was requested but no additional information was reported on degree of burn or if an intervention was needed.
 
Manufacturer Narrative
One device was received for investigation. The device was received without the hose or power supply. A review of the device history record, for the reported serial number, found that the device had been received in the past for repairs and was originally used as a demonstration device. Visual inspection found that the device and filter were in good condition. During functional testing, a known good hose and power cord were attached to the warming device and the unit was plugged in. The device performed its self-test with no issues observed. The device was set to each of its three different temperature settings; all temperatures were found within specification. The temperature was then measured while the device was 75% and 100% occluded; the device passed both tests. The warming device was forced into over and under temperature and at each temperature setting; the device passed all tests. During all three forced overheating simulations, the alarm sounded and the warming device shut itself off within temperature specifications. The device was then set to each of its three different temperature settings for an extended period of time; all temperatures remained within specification. As the returned device operated in specification, no evidence was found to suggest the reported event was related to an intrinsic product fault. (b)(4). Please note, investigation results for mfr# 2183502-2016-01656 was originally submitted under mfr#: 2183502-2016-01655. Supplemental report sent to correct error.
 
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Brand NameLEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SMITHS MEDICAL ASD INC.
1265 grey fox road
st. paul MN 55112
Manufacturer (Section G)
SMITHS MEDICAL OAKDALE
3350 granada avenue north
suite 100
oakdale MN 55128
Manufacturer Contact
lisa perz
1265 grey fox rd
st. paul, MN 55112
7633833074
MDR Report Key5843504
MDR Text Key51051892
Report Number2183502-2016-01656
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCON-EQ-5000
Device Lot NumberS10004711
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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