BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOVO

    MDR report key: 16460346 · Received March 1, 2023

    Report

    Report Number
    1062191-2022-00002
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    July 31, 2022
    Report Date
    March 1, 2023
    Manufacturer
    INOVO, INC
    Product Code
    NFB
    UDI-DI
    00822383018515
    PMA / PMN Number
    K103392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INOVO INC. WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONSERVER BY A PROVIDER WHO STATED THAT "AN END USER ATTACHED A FULL CYLINDER TO THE OXYGEN CONSERVER AND WHEN HE OPENED THE CYLINDER A LARGE FLASH WAS SEEN." THE END USER IMMEDIATELY CLOSED THE CYLINDER VALVE. IT WAS REPORTED THAT A LARGE AMOUNT OF SOOT WAS SEEN AROUND THE CYLINDER VALVE AND OXYGEN CONSERVER. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. INOVO EVALUATED THE PRODUCT, WHICH SUGGESTED THAT THE IGNITION MECHANISM WAS FLOW FRICTION, WHICH CAN OCCUR IF THE SEAL WASHER WEARS OVER TIME, OR IF THE DEVICE IS NOT CONNECTED TO THE COMPRESSED OXYGEN CYLINDER TIGHTLY ENOUGH, BOTH OF WHICH ARE SPECIFICALLY ADDRESSED BY THE DEVICE'S INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436059 INOVO CONSERVER, OXYGEN NFB INOVO, INC OM-900A 00822383018515

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown