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

Model Number	30B-S
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/13/2019
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 "according to the clinical staff, they saw sparks coming from the machine." there was no reported patient involvement.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: 8740505
• Report Number: 3012446970-2019-00017
• Device Sequence Number: 1591185
• Product Code: JOW
• UDI-Device Identifier: 00888912306553
• UDI-Public: 00888912306553
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/27/2019

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1