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

Catalog Number L1-CW-220V

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem Burn(s) (1757)

Event Date 05/15/2019

Event Type  malfunction  

Event Description

It was reported that while a smiths medical level 1 convective warmer was in use, the heater started disbursing smoke from the nozzle and orifices of the blanket.Given the black smoke, the patient and the blanket where marked/burned at the exit orifices.Product did not stop on its own, and was set to 37 degrees celsius.

Manufacturer Narrative

Investigation results completed on a smiths medical convective warming|level 1 blowers.The complaint of black smoke and patient along with blanket had a marked burn at the exit orifices.Photo provided on blanket of burn but not patient.History log revealed button stuck, over temp error, over temp lockout reset, distal error.Testing was done and with powering of device temperature ranges within specification 37.40 and 43.Testing was done at different intervals and over two hour ranges with blanket showing no visual changes or burns to blanket and tco testing passed.However, upon opening device, it was discovered the preventative maintenance was done by replacing exit muffler, heater assembly and blower assembly.Device passed all functional testing.

Event Description

Investigation completed on convective warmer and summarized.

• Brand Name: SMITHS MEDICAL CONVECTIVE WARMING LEVEL 1 BLOWER
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8691770
• MDR Text Key: 147744158
• Report Number: 3012307300-2019-03202
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: L1-CW-220V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 60