MAUDE Adverse Event Report: ST PAUL LEVEL 1; SYSTEM, THERMAL REGULATING

Model Number	SW5-HOSE-7
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient was burned on his left arm and on the back.The patient was on her stomach.The equipment was used at 44c during intervention (duration not available).As soon the equipment was overtemperature, the team immediately stopped the equipment.No medical or surgical intervention was reported.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The device was returned for evaluation.Visual and functional testing were performed.No issues found with the hose or device.Functional testing found the device and hose performed as intended.The root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.Operator of device is unknown.No product information has been provided to date.

• Brand Name: LEVEL 1
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; bp 36; minneapolis, MN 55442
• MDR Report Key: 15272058
• Report Number: 3012307300-2022-15802
• Device Sequence Number: 20451963
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: SW5-HOSE-7
• Device Catalogue Number: SW5-HOSE-7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Female