MAUDE Adverse Event Report: ST PAUL LEVEL 1 EQUATOR BLOWER; SYSTEM, THERMAL REGULATING

Catalog Number CON-EQ-5000HF-115V

Device Problems Gradient Increase (1270); Failure to Sense (1559); Temperature Problem (3022)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation results: one level 1 equator blower was returned for investigation in used condition.Wear and tear damage was noted on the following components: membrane switch, top enclosure, and bottom enclosure.Following the visual inspection, the investigator attached a test hose, plugged in the line cord, pressed the green button, and selected the 44 degree option on the keypad.The investigator then ran the device for 20 hours using a test hose and observing the temperature with a digital thermometer which was attached to the end of the hose.The investigator was unable to reproduce the over temperature state reported by the customer.The temperature of the unit did not rise above 43.9 degrees during the test.The device functioned as intended.No fault was found with the device.

Event Description

It was reported that during an ophthalmology procedure, the smiths medical level 1 equator blower exceeded the set temperature by three degrees.A gown, sheet, and blanket were covering the skin of the patient.The high temperature resulted in the patient experiencing second degree burns.This was observed about ten minutes into the procedure.The warmer was turned off after the patient temperature, which was being monitored esophageally, began to rise.The patient was treated for the second degree burns.The condition of the patient was being monitored.No further complications were reported in relation to the event.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).

• Brand Name: LEVEL 1 EQUATOR BLOWER
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10795899
• MDR Text Key: 215010765
• Report Number: 3012307300-2020-11032
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CON-EQ-5000HF-115V
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other