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

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).

• Brand Name: LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE
• Type of Device: SYSTEM, 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 Key: 5836439
• MDR Text Key: 50835808
• Report Number: 2183502-2016-01386
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• 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 Received: 08/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EQ-5000-FR-230V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention