MAUDE Adverse Event Report: ENCOMPASS GROUP, LLC NOVA; PATIENT WARMING SYSTEM

Model Number	AW5100-300
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Note: report delayed due to delayed sign up process; first time submitting adverse event.

• Brand Name: NOVA
• Common Device Name: PATIENT WARMING SYSTEM
• Manufacturer (Section D): ENCOMPASS GROUP, LLC; 615 macon street; mcdonough GA 30253
• MDR Report Key: 12216778
• Report Number: 1043644-2021-00001
• Device Sequence Number: 4377050
• Product Code: DWJ
• UDI-Device Identifier: 00612899006492
• UDI-Public: 00612899006492
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K203085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

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: AW5100-300
• Device Lot Number: 1971322
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/23/2021
• 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: 76 YR