BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT VENTILATOR DUAL HEATED CIRCUIT KIT

    MDR report key: 11518503 · Received March 18, 2021

    Report

    Report Number
    9611451-2021-00262
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    February 3, 2021
    Report Date
    February 17, 2021
    Product Code
    BZE
    UDI-DI
    09420012436825
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (950A81 CIRCUIT) IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K122432. METHOD: THE TWO COMPLAINT 950A81 CIRCUITS WERE RETURNED TO F&P IN NEW ZEALAND FOR INVESTIGATION WHERE THEY WERE VISUALLY INSPECTED. RESULT: VISUAL INSPECTION OF THE COMPLAINT 950A81 CIRCUITS REVEALED STRESS CRACKS ON THE SIDE OF THE CONNECTOR ELBOWS OF THE EXPIRATORY LIMBS AND THE TUBING WAS TORN. CONCLUSION: THE NATURE OF THE DAMAGE INDICATES THAT THE COMPLAINT 950A81 CIRCUITS LIKELY CAME INTO CONTACT WITH A SOLUTION CONTAINING ALCOHOL. OUR USER INSTRUCTIONS THAT ACCOMPANY THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KITS STATE THE FOLLOWING: DO NOT CLEAN OR STERILIZE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS OR HAND SANITIZERS.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN THE NETHERLANDS REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE CONNECTOR ON THE VENTILATOR PORT OF THE EXPIRATORY LIMB OF TWO 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KITS WERE DAMAGED DURING PATIENT USE. THERE WERE NO PATIENT CONSEQUENCES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K122432. THE TWO COMPLAINT 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KITS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN THE (B)(6) REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE CONNECTOR ON THE VENTILATOR PORT OF THE EXPIRATORY LIMB OF TWO 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KITS WERE DAMAGED DURING PATIENT USE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419224 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT BZE BZE 950A81 2101313702 09420012436825

    Patients

    Seq Age Sex Outcome Treatment
    1