• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE SYSTEM, THERMAL REGULATING

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS HEALTHCARE MFG LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number EQ-5000-FR-230V
Device Problems Device Alarm System (1012); Insufficient Information (3190)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 06/08/2016
Event Type  Injury  
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
This event occured in (b)(6). User facility reported that the device was in use with a patient during a valve plasty surgery for approximately 4 hours. According to reporter, the patient sustained a second degree burn on the leg. Reporter stated the device was in use on the lowest temperature setting (36 degrees c). The patient's burns were treated with paraffin tulles. No permanent adverse effects reported. Unknown patients condition at this time. Please reference mdr#: 2183502-2016-01385 for associated complaint.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Further information was received from the user facility that during the procedure a vesical probe temperature and esophagus intubation equipment were utilized with the equator convective warming device. It was also reported that there were no alarms that went off during the procedure on the device, and the patient was covered except on the scarpas (both parts), thorax and head. During and after the procedure the patient's temperature remained at 36. 4 degrees c, but the patient's temperature was warmed by extracorporal circulation between the temperature of 35. 5 and 37. 3 degree c. It was also reported that the patient did receive intravenous fluids; isofundinz and ringer lactate before and during use of the warming blanket. Additional information was also received on the patient that they didn't have peripheral vascular disease or low cardiac output, and that the patient is having a rapid recovery.
 
Manufacturer Narrative
The french equator device was received in used condition with 2013 manufacture date. Device was returned with power cord but no hose. Dings on case and handle were visually seen. The filter was acceptable. Device was fitted with test hose and connected to 230v power source and powered on. Multiple functional testing's were performed and they all passed including an over temp alarm which occurred at 39 degrees c for 36 degree setting, 43 degrees at 40 degree setting, and at 47 degree c when tested at 44 degrees. These are all passing temperatures. No fault found; customer issue not confirmed. (b)(4).
 
Manufacturer Narrative
(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana 55425
MX 55425
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana 55425
MX 55425
Manufacturer Contact
lisa perz
1265 grey fox rd
st. paul, MN 55112
7633833074
MDR Report Key5836439
MDR Text Key50835808
Report Number2183502-2016-01386
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 consumer,foreign,health profe
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 06/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEQ-5000-FR-230V
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/01/2016 Patient Sequence Number: 1
-
-