BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    880 HUMIDIFICATION SYSTEM

    MDR report key: 1651097 · Received March 31, 2010

    Report

    Report Number
    9611451-2010-00199
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Date of Event
    March 19, 2010
    Report Date
    March 19, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS NOT SOLD IN THE USA BUT SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510 (K) FOR THAT PRODUCT IS K073706. THE RETURNED CIRCUITS WERE VISUALLY INSPECTED. RESULTS: ALL EIGHT CIRCUIT KITS HAD THE INCORRECT DRY LINE PACKED. CONCLUSION: PRODUCTION STAFF HAVE BEEN ALERTED TO ENSURE THAT CORRECT PARTS ARE PACKED DURING THE ASSEMBLY PROCESS. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT WHEN A CLINICAL NURSE OPENED AN RT241 BREATHING CIRCUIT TO ATTACH TO AN MR880 HUMIDIFIER, SHE DISCOVERED, THERE WAS NO OXYGEN ADAPTER ATTACHED TO THE INSPIRATORY TUBE. THIS FAULT WAS NOTICED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 880 HUMIDIFICATION SYSTEM NONE BTT FISHER & PAYKEL HEALTHCARE LTD RT241 100312

    Patients

    Seq Age Sex Outcome Treatment
    1