BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARTNER LLI

    MDR report key: 118468 · Received September 2, 1997

    Report

    Report Number
    2021710-1997-00018
    Event Type
    Malfunction
    Date Received
    September 2, 1997
    Date of Event
    July 30, 1997
    Report Date
    August 4, 1997
    Manufacturer
    BIRD PRODUCTS CORP.
    Product Code
    BZQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    WHEN USING AN INFANT FLOW SENSOR, AN ACCESSORY OF THIS DEVICE, HOSP STAFF NOTICED THAT ONE OF THE TWO FILTER SCREENS (ONE ON EACH END) WAS MISSING. THE SCREEN WAS FOUND IN THE SWIVEL ADAPTOR ATTACHED TO THE BABY'S TRACHEOSTOMY TUBE. THIS SCREEN DID NOT MIGRATE INTO THE TRACHEOSTOMY TUBE AND THIS SCREEN DID NOT OBSTRUCT AIR FLOW. A SERIAL NUMBER WAS NOT PROVIDED AS IT WAS NOT KNOWN AND AS THE REPORTED EVENT WAS AGAINST THE P/N 15420 INFANT FLOW SENSOR, AN ACCESSORY OF THIS DEVICE, AND NOT THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARTNER LLI VOLUME MONITOR BZQ BIRD PRODUCTS CORP. 15285 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * PORTEX SWIVEL ADAPTOR