MAUDE Adverse Event Report: INNOVAMED HEALTH, LLC AIRCAST VENAPRO SYSTEM; SLEEVE, LIMB, COMPRESSIBLE

Model Number	30M
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2020
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 venapro system was overheating during treatment.There was no reported patient harm.

• Brand Name: AIRCAST VENAPRO SYSTEM
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): INNOVAMED HEALTH, LLC; 2441 s. 1560 west; woods cross, ut
• MDR Report Key: 9716534
• Report Number: 3005844491-2020-00003
• Device Sequence Number: 16232052
• Product Code: JOW
• UDI-Device Identifier: 00190446273288
• UDI-Public: 00190446273288
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2020

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: Lay User/Patient
• Device Model Number: 30M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1