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

Model Number EQ-5000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 07/28/2017

Event Type  malfunction  

Event Description

It was reported that a patient sustained a first degree burn on the left forearm with the use of a level 1® equator® convective warming device.This was after 4 hours and 30 minutes of use of the device.The patient was positioned in a supine position with the arms crossed.The operating temperature was 40 degrees celsius.Clinicians ensured that the installation was non-compressive.No other adverse health outcomes were reported.

Manufacturer Narrative

The returned hose was evaluated.Visual inspection found the hose in good condition.Functional testing involved resistance testing on the hose thermistor and found resistance values to be normal.Functional testing involved use testing with known good main device and found to be in working order.The hose was found to have operated as intended.

Manufacturer Narrative

One device was returned for evaluation with hose and power cord.Visual inspection found that the hose serial number did not match the device serial number.It was observed that the filter was dirty.Functional testing involved a temperature test and all temperature settings were found to be within specifications.Based on the evidence, the complaint was unable to be confirmed.The device operated as intended.

Event Description

The patient was in a dorsal recumbent position with arms crossed.The blanket was in transversal position.The hose was on the left side of the blanket and was not in contact with the patient.The burns were observed after more than 4 hours of continued use.The injury disappeared after 1 hour.The event was considered resolved.

• Brand Name: LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 6829743
• MDR Text Key: 83965639
• Report Number: 3012307300-2017-01971
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EQ-5000
• Device Catalogue Number: EQ-5000-FR-230V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 09/08/2017; 11/29/2017
• Supplement Dates FDA Received: 10/17/2017; 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2013
• 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
• Treatment: LEVEL 1® SNUGGLE WARM® BLANKET
• Patient Age: 51 YR
• Patient Weight: 53