MAUDE Adverse Event Report: DJO LLC. AIRCAST VF ELITE SYSTEM W/BATTERY; SLEEVE, LIMB, COMPRESSIBLE

Model Number	30B-B
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter info: unknown.No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Event or Problem Description
It was reported that the "venaflow elite unit caught fire in the operating room.No one was injured and the fire department was called to the scene.The machine was cleared to go back into the building by the fire marshall after the scene was cleared." no further information is currently available.

• Brand Name: AIRCAST VF ELITE SYSTEM W/BATTERY
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): DJO LLC.; 1430 decision street; vista, ca
• MDR Report Key: 10326530
• Report Number: 3012446970-2020-00023
• Device Sequence Number: 3162794
• Product Code: JOW
• UDI-Device Identifier: 00888912306539
• UDI-Public: 00888912306539
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122499
• 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
• Report Date (Section B): 07/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 30B-B
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1