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	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter information: unknown.The unit has been discarded by the user facility.As such, no product evaluation can be performed.
Event or Problem Description
It was reported that the "venaflow unit in or (operating room) began smoking and started on fire.The unit was plugged in at the time, but not in use on a patient.".

• 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: 9774031
• Report Number: 3012446970-2020-00006
• Device Sequence Number: 2185633
• 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): 03/01/2020

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: Health Professional
• Device Model Number: 30B-B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1