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

Model Number AW5100-300

Device Problem Insufficient Information (3190)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 06/17/2021

Event Type  Injury  

Manufacturer Narrative

Note: report delayed due to delayed sign up process; first time submitting adverse event.

• Brand Name: NOVA
• Type of Device: PATIENT WARMING SYSTEM
• Manufacturer (Section D): ENCOMPASS GROUP, LLC; 615 macon street; mcdonough GA 30253
• Manufacturer (Section G): ENCOMPASS GROUP, LLC; 615 macon street; mcdonough GA 30253
• Manufacturer Contact: jessica lester ; 615 macon street; mcdonough, GA 30253 ; 7706262172
• MDR Report Key: 12216778
• MDR Text Key: 263392550
• Report Number: 1043644-2021-00001
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00612899006492
• UDI-Public: 00612899006492
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: AW5100-300
• Device Lot Number: 1971322
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR