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

Catalog Number	SWU-2003
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	Malfunction
Event or Problem Description
It was reported that the patient sustained burns and blisters (phlyctene) following use of the equator warming blanket.The equator heated to 48 degrees instead of heating to 44 degrees.The device had to be changed.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
The convective warmer was returned for evaluation with the thermistor convective warmer hose.The hose was connected and these items were tested together.The warmer was given functional testing at all three of the temperature settings and the temperature output did not exceed acceptable temperature output during testing.The returned device was also tested for functionality of the over temperature alarm.The warmer's over temperature alarms were found to function as specified; the device would shut down once specified temperature limit had been reached at all three temperature settings.The reported issue could not be confirmed to have been device-caused.The returned device was found to operate as specified.One convective warming blanket was received for evaluation.The examination of the returned blanket showed no discrepancies.The blanket was given functional testing with an equator convective warmer.The blanket was attached to the warmer thermistor hose as per device instructions.The testing showed the blanket fully inflated and all seals between the upper and lower sections were intact.No delamination was detected and all of the vent holes were present.No air flow obstructions were found.The returned device was found to function as expected.Functional testing could not confirm any intrinsic device problems.The manufacturing facility performed a review of the manufacturing process for convective warming blankets.The review showed that assembly process was being performed as per procedure.The manufacturing process includes a sampling of assembled blankets where functional testing is performed.The review showed functional testing was being performed as per manufacturing procedures.

• 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: 7537115
• Report Number: 3012307300-2018-01632
• Device Sequence Number: 217848
• Product Code: DWJ
• UDI-Device Identifier: 10610586043345
• UDI-Public: 10610586043345
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141686
• 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): 11/16/2018

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 Expiration Date: 12/19/2020
• Device Catalogue Number: SWU-2003
• Device Lot Number: 3549956
• 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: 08/13/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 11/16/2018
• 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: Other
• Patient Age: 64 YR
• Patient Weight: 80