BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 4120294 · Received September 26, 2014

    Report

    Report Number
    9611451-2014-00782
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 28, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION AND ARRIVED IN A CONDITION WHICH MADE IT IMPOSSIBLE FOR THE INVESTIGATION TO BE COMPLETED. RESULTS: THE CHAMBER HAD BEEN CRUSHED AND THE CHAMBER DOME WAS CRACKED. THE BASE OF THE DOME WAS DENTED AND WARPED. THE RT265 INFANT BREATHING CIRCUIT WAS ALSO DAMAGED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 140507. CONCLUSION: THE DAMAGE TO THE COMPLAINT DEVICE WAS CAUSED BY TRANSPORTATION. DUE TO THE EXTENSIVE DAMAGE TO THE COMPLAINT DEVICE, WE WERE UNABLE TO PERFORM ANY TESTING AND THEREFORE WERE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM REPORTED BY THE CUSTOMER. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE THE FOLLOWING: - "SET APPROPRIATE VENTILATOR ALARM." - "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." FISHER & PAYKEL HEALTHCARE HAS CONTACTED THE TRANSPORTATION COMPANY TO ENQUIRE ON THE SOURCE OF THE DAMAGE WHICH PREVENTED THE DEVICE INVESTIGATION

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN MR290 HUMIDIFICATION CHAMBER WAS PRODUCING A RHYTHMIC WHISTLE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602141 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 140507

    Patients

    Seq Age Sex Outcome Treatment
    1 DRÄGER INFINITY C500 VENTILATOR| FISHER & PAYKEL RT265 BREATHING CIRCUIT KIT