BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POM

    MDR report key: 7781037 · Received August 14, 2018

    Report

    Report Number
    3010411911-2018-00002
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Date of Event
    April 9, 2018
    Report Date
    August 13, 2018
    Manufacturer
    POM MEDICAL, LLC.
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE THAT THERE WAS NO PATIENT ILLNESS, INJURY OR DEATH FOR THIS COMPLAINT, THE MANUFACTURER IS FILING A MDR DUE TO THE CORRECTIVE ACTIONS TAKEN RELATED TO THIS PRODUCT PROBLEM AND THE FORMAL DECISION TO VOLUNTARY RECALL PRODUCT ON JULY 11, 2018.

    Description of Event or Problem · 1

    AS NOTED BY THE COMPLAINANT, WHEN THE OXYGEN LINE IS CONNECTED TO THE HIGH CONCENTRATION ADAPTER WITH RE-BREATHER BAG, THE OXYGEN LINE "POPS OFF" AFTER THE OXYGEN IS TURNED ON DUE TO A CLOGGED PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623944 POM POM 1001-MM BYG POM MEDICAL, LLC. POM 1001-MM 021418-021421

    Patients

    Seq Age Sex Outcome Treatment
    1