BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD 1500 HME

    MDR report key: 4881686 · Received July 1, 2015

    Report

    Report Number
    3011270181-2015-00005
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 4, 2015
    Report Date
    August 18, 2015
    Manufacturer
    HALYARD HEALTH
    Product Code
    BYD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT INVOLVED IN THE REPORT WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESPIRATORY THERAPIST STAFF OBSERVED THE HEAT AND MOISTURE EXCHANGER FILLING UP WITH MOISTURE FASTER THAN EXPECTED CAUSING THE VENTS TO ALARM CIRCUIT OCCLUSION. THE RESPIRATORY THERAPIST NOTED THAT THE WEIGHT APPEARED TO BE HIGHER THAN EXPECTED AND THE DEVICE REQUIRED CHANGING MORE OFTEN AFTER INITIATION. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427779 BALLARD 1500 HME VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES BYD HALYARD HEALTH 153 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1