BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRCAST

    MDR report key: 6421137 · Received March 21, 2017

    Report

    Report Number
    3005844491-2017-00001
    Event Type
    Malfunction
    Date Received
    March 21, 2017
    Date of Event
    March 13, 2017
    Report Date
    March 21, 2017
    Manufacturer
    INNOVAMED HEALTH LLC
    Product Code
    JOW
    PMA / PMN Number
    K133274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER EXEMPTION E2015057. (B)(4). NOT RETURNED.

    Description of Event or Problem · 0

    COMPLAINT RECEIVED THAT ALLEGES "UNIT STARTED TO OVERHEAT AND ACTUALLY MELT". QUESTIONNAIRE NOT RECEIVED FROM CUSTOMER OR CLINICIAN. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, PERMANENT IMPAIRMENT OR DEATH.

    Additional Manufacturer Narrative · 1

    COMPLAINT STATUS: NOT VALIDATED, THERE WAS NO SIGN OF OVERHEATING DURING RETURN INSPECTION DURING PUMP ACTIVATION, PUMP TEMPERATURE INCREASED 6'C AND THE VALVE INCREASED 8'C FROM AMBIENT. DURING RECHARGE FROM A LOW BATTERY INDICATION ON VENPRO UNIT, R2 TEMPERATURE INCREASED 13'C FROM AMBIENT. DURING OPERATION NO NOTICEABLE HEAT WAS PERCEIVED FROM THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203081 AIRCAST VENAPRO SYSTEM JOW INNOVAMED HEALTH LLC 30M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other