BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WESTMED LLC

    MDR report key: 16470158 · Received March 2, 2023

    Report

    Report Number
    2028807-2023-00003
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    January 22, 2023
    Report Date
    February 1, 2023
    Manufacturer
    WESTMED LLC
    Product Code
    NHK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTABLE AS IT WAS AN INTERRUPTION AND DELAY OF THERAPY.

    Additional Manufacturer Narrative · 0

    REPORTABLE AS IT WAS AN INTERRUPTION AND DELAY OF THERAPY. COMPLAINT WAS CONFIRMED. ROOT CAUSE COULD NOT BE DETERMINED FOR IF THE COMPLAINT WAS DUE TO ASSEMBLY ERROR OR HANDLING ERROR WHEN DEVICE WAS BEING PREPPED FOR USE. INVENTORY COULD NOT REPEAT THE REPORTED DEFECT; HOWEVER, AN ADDITIONAL INSPECTION WAS CREATED TO ENSURE PRODUCT MAINTAINS PULL FORCE CONSISTENCY.

    Description of Event or Problem · 0

    RESERVOIR BAG DETACHED FROM RESUSCITATION DEVICE AND WOULD NOT STAY ATTACHED WHEN TRYING TO RE ATTACH. THE MASK ALSO REPEATEDLY FELL OFF, UNABLE TO GIVE PATIENT ADEQUATE BREATHS UNTIL A NEW DEVICE WAS RETRIEVED FOR USE.

    Description of Event or Problem · 0

    RESERVOIR BAG DETACHED FROM RESUSCITATION DEVICE AND WOULD NOT STAY ATTACHED WHEN TRYING TO RE ATTACH. THE MASK ALSO REPEATEDLY FELL OFF, UNABLE TO GIVE PATIENT ADEQUATE BREATHS UNTIL A NEW DEVICE WAS RETRIEVED FOR USE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011866 WESTMED LLC ADULT BAGEASY, RESUSCITATOR, W/PEEP,MASK 14' O2 TUBING NHK WESTMED LLC 562234 051022U17

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other