BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRCAST VENAPRO SYSTEM

    MDR report key: 8659777 · Received May 31, 2019

    Report

    Report Number
    3005844491-2019-00002
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 9, 2019
    Report Date
    March 18, 2020
    Manufacturer
    INNOVAMED HEALTH, LLC
    Product Code
    JOW
    UDI-DI
    00190446273288
    PMA / PMN Number
    K133274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE VENAPRO SYSTEM WAS RETURNED FOR EVALUATION. THE REPORTED PROBLEM WAS CONFIRMED. BOTH PUMPS WERE OVERHEATING WHILE CHARGING.

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT EVALUATION. PER EXEMPTION NUMBER E2015057.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING. THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452603 AIRCAST VENAPRO SYSTEM SLEEVE, LIMB, COMPRESSIBLE JOW INNOVAMED HEALTH, LLC 30M 00190446273288

    Patients

    Seq Age Sex Outcome Treatment
    1