MAUDE Adverse Event Report: ST PAUL LEVEL 1; CONVECTIVE WARMING|ACCESSORIES

Model Number	SW5-HOSE-7
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical convective warming|level 1 equator blowers caused a second degree burn to patient upper arm and upper body were provided to reveal the blisters and redness covering the entire upper alarm and shoulder.9% body surface burn.The temperature was reported at 35.5 c before using and 35.9 c after finding out the burn when she woke up four hours from the beginning of medical procedure of left colectomy.Information revealed patient was receiving wound treatment for burns per hospital procedure daily.No further information at this time.
Additional Manufacturer Narrative
One convective warming hose was received bent, but not broken.The hose and power cord were plugged in.Selecting and running about 1 hour on each temperature, without any big difference between selected temp and real temp, on the 36 and 40, the real temp was with 0.5 degree more and on 44 with about 1 degree more.Another test with a new hose was performed, but the difference was the same.The reported issue was unable to be confirmed.There was no fault found with the returned pump.

• Brand Name: LEVEL 1
• Common Device Name: CONVECTIVE WARMING|ACCESSORIES
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10247319
• Report Number: 3012307300-2020-07044
• Device Sequence Number: 10896666
• Product Code: DWJ
• UDI-Device Identifier: 50695085000653
• UDI-Public: 50695085000653
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K011907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SW5-HOSE-7
• Device Catalogue Number: SW5-HOSE-7
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 62