MAUDE Adverse Event Report: DJO, LLC AIRCAST VENAFLOW ELITE SYSTEM, WITH S-MODE; SLEEVE, LIMB, COMPRESSIBLE

Model Number	30B-S
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 unit was "smoking, nothing appeared to precipitate".No further information is currently available.

• Brand Name: AIRCAST VENAFLOW ELITE SYSTEM, WITH S-MODE
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 9009692
• Report Number: 3012446970-2019-00029
• Device Sequence Number: 1891498
• Product Code: JOW
• UDI-Device Identifier: 00888912306553
• UDI-Public: 00888912306553
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130722
• 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): 09/12/2019

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-S
• Device Lot Number: E45773
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1