MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 EQUATOR BLOWERS; SYSTEM, THERMAL REGULATING

Catalog Number EQ-5000-FR-230V

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 04/26/2018

Event Type  Injury  

Event Description

It was reported that the patient sustained burns and blisters (phlyctene) following use of the warming blanket.With current information available it is not clear whether any treatment was required to preclude permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

One equator was returned for analysis in fair condition with the hose and power cord.Visual exam brought back the following: filter was clean, hose serial number did not match device serial number, wiring connections found to be tight.Occlusion tests performed; no discrepancies.Display accuracy was checked by selecting 36, 40, and 44 degrees set points; values were as selected.Performed over temperature alarm test at 36, 40, and 44 degrees.Device alarmed over temperature at 38, 43, and 47 degrees; passing check.Installed temperature probe e5641 due jan 2019 and digital voltmeter e3213 due nov 2018 and powered on device.Selected 36 degree setting and ran dut for 2 hours.Measured temperature was found to be 36.92 degrees.In the process of setting up 40 degree test, f4 fuse located on control board blew.This is a soldered in fuse.Replaced fuse and continued with test.Fuse replacement did not affect test results.Selected 40 degree setting and ran device for 2 hours.Measured temperature was 40.70 degrees.Selected 44 degree setting and ran device for 2 hours.Measured temperature was 44.53 degrees.All three temperature values were found to be within tolerance.Based on the evidence, the root cause is unknown as the complaint is not confirmed.

• Brand Name: LEVEL 1 EQUATOR BLOWERS
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7537106
• MDR Text Key: 109017562
• Report Number: 3012307300-2018-01630
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: EQ-5000-FR-230V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 80