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	07/01/2020
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 device shorted out and shot sparks.They said there were no injuries, but the unit tripped the circuit breaker for the room it was in.There is a hole in the power cord where it looks like the wires touched." device not received by manufacturer at this time.Manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
It was reported that " the device shorted out and shot sparks.They said there were no injuries, but the unit tripped the circuit breaker for the room it was in.There is a hole in the power cord where it looks like the wires touched." device not received by manufacturer at this time.Manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
H3, h6: device was returned for evaluation.Power cord was replaced.All testing and burn-in was sucessfully performed.

• 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
• MDR Report Key: 10326531
• Report Number: 3012446970-2020-00024
• Device Sequence Number: 11554065
• Product Code: JOW
• UDI-Device Identifier: 00888912306553
• UDI-Public: 00888912306553
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K130722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2020

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: No Information
• Device Model Number: 30B-S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1