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	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Operator of device, health professional, occupation: 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 "pump got hot and turned off last night when it was plugged in".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: 9717630
• Report Number: 3005844491-2020-00013
• Device Sequence Number: 366616
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2020

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: 30M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2020
• 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