BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIOS

    MDR report key: 10805066 · Received November 6, 2020

    Report

    Report Number
    3003767629-2020-00001
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    October 7, 2020
    Report Date
    November 6, 2020
    Manufacturer
    PARI RESPIRATORY EQUIPMENT, INC. - MIKE JUDGE
    Product Code
    CAF
    UDI-DI
    00744229310679
    PMA / PMN Number
    K092918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN ISOLATED INCIDENT AT THIS TIME. AFTER SEVERAL CALLS WITH THE PATIENT AND A DISCUSSION WITH THE PHYSICAL THERAPIST, WE HAVE BEEN UNABLE TO RETRIEVE THE DEVICE FOR EVALUATION. WE ATTEMPTED TO HAVE AN ELECTRICIAN COME TO THE HOUSE AND INSPECT THE DEVICE AND THE WALL OUTLET, BUT THE PATIENT GAVE CONFLICTING INFORMATION AS TO THE DEVICE'S WHEREABOUTS, PRECLUDING SUCH ON-SITE INSPECTION. OUR CONVERSATIONS WITH THE PATIENT WERE CHALLENGING, AS SHE WAS UPSET, SEEMED CONFUSED, AND WAS DIFFICULT TO UNDERSTAND. PATIENT REFUSED TO ACCEPT REPLACEMENT PRODUCT. OUR INVESTIGATION OF PRODUCTION RECORDS AND DATA DID NOT IDENTIFY ANYTHING THAT WOULD CONTRIBUTE TO SUCH A MALFUNCTION, AND WE HAVE NOT RECEIVED ANY OTHER SIMILAR REPORTS FOR THIS PRODUCT FROM THIS PRODUCTION PERIOD. NEVERTHELESS, SINCE WE ARE UNABLE TO OBTAIN ADEQUATE INFORMATION FROM THE PATIENT OR EVALUATE THE PRODUCT, WE ARE SUBMITTING THIS FORM FDA 3500A.

    Description of Event or Problem · 1

    ELECTRICAL EVENT [DEVICE ELECTRICAL FINDING]. ON (B)(6) 2020, A SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER REGARDING A (B)(6) YEAR-OLD FEMALE PATIENT'S EXPERIENCE WITH VIOS (NEBULIZER). THE PATIENT WAS NOTED TO BLIND AND IN A WHEELCHAIR. ON (B)(6) 2020, THE CONSUMER STATED THAT WHEN HER PHYSICAL THERAPIST PLUGGED THE COMPRESSOR POWER CORD INTO THE WALL OUTLET, THEY SAW FLAMES COME OUT OF THE OUTLET. NEITHER PATIENT NOR THERAPIST WERE INJURED ACCORDING TO THE THERAPIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262707 VIOS NEBULIZER (DIRECT PATIENT INTERFACE) CAF PARI RESPIRATORY EQUIPMENT, INC. - MIKE JUDGE 310F83-LC+ 00744229310679

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR