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

Catalog Number	SW5-HOSE-7
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); Injury (2348)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacture and expiry information could not be determined with information provided.
Event or Problem Description
It was reported that the during an abdominoperineal amputation, the patient sustained burns and blisters (phlyctene) at the arms and chest, following use of the equator warming blanket.The traces of burns had been observed at the removal of the drapes.With the 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.
Additional Manufacturer Narrative
One hose from the device was returned for evaluation.Hose was received in used condition and connected to known good test device.Device and hose functioned as intended.Customer complaint was not confirmed.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: LEVEL 1 EQUATOR BLOWERS
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7537127
• Report Number: 3012307300-2018-01633
• Device Sequence Number: 2481879
• 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): 04/23/2019

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: No Information
• Device Catalogue Number: SW5-HOSE-7
• Device Lot Number: N2070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR