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

Catalog Number	CON-EQ-5000HF-115V
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent cardiac procedure and sustained a 3 percent bsa burn of her right leg after the device was detached from the warming blanket.Later inspection found that the warming device was blowing significantly hotter air than set temperatures.The outcome of the injury is unknown.
Additional Manufacturer Narrative
H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H6 evaluation codes: updated.No product or photographic evidence was provided for the investigation.Therefore, we cannot confirm the reported complaint.If we received the device, we will reopen the investigation and send a supplemental report.Based on the reported problems, the most probable causes would be either the device temperature control was out of calibration, or the device was improperly used.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.
Additional Manufacturer Narrative
Section a patient information updated, description of the event was clarified; section e initial reporter information was corrected.The device was not returned for evaluation and no pictures or other relevant information was provided to conduct an evaluation of the device.The service history was reviewed.The device has not been previously serviced.Search of the complaint database shows that one prior complaint has been received for the unit related to high temperature; however, the unit was not returned, and the root cause was unable to be determined.The complaint was unable to be confirmed.The root cause was unable to be determined.
Event or Problem Description
It was reported that a patient underwent a cardiac procedure and sustained a 3 percent bsa burn of her right leg after the level 1¿ convective warmer device was detached from a warming blanket.It is further alleged that later inspection found that the warming device was blowing significantly hotter air than set temperatures.The patient is reported to have undergone excisional debridement and split thickness autografting for wound closure to the burns on the right leg.

• Brand Name: LEVEL 1 CONVECTIVE WARMER
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18411023
• Report Number: 3012307300-2023-12248
• Device Sequence Number: 2761073
• Product Code: DWJ
• UDI-Device Identifier: 15019517116175
• UDI-Public: (01)15019517116175(11)150223(21)S102A02968
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/15/2024

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 Catalogue Number: CON-EQ-5000HF-115V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 02/16/2024; 02/16/2024; 07/31/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 03/13/2024; 03/21/2024; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American