BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1883590 · Received October 26, 2010

    Report

    Report Number
    9611451-2010-00639
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ()B)(4). TWO OF THE THREE COMPLAINT CHAMBERS ARE AVAILABLE FOR INVESTIGATION. THE THIRD WAS DISCARDED BY THE HOSPITAL. THE CHAMBERS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICES AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO OF THE THREE COMPLAINT CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE ((B)(4)) FOR INVESTIGATION. THE RETURNED CHAMBERS WERE VISUALLY INSPECTED FOR DAMAGE. RESULTS: BOTH OF THE CHAMBERS WERE CRACKED ON THE FRONT BAFFLE, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 091004. CONCLUSION: CRACKS IN THE CHAMBER DOME MAY OCCUR IF THE CHAMBER IS IMPACTED OR USED OUTSIDE OF THE RECOMMENDED SETTINGS. THE MR290 USER INSTRUCTIONS ADVISE THE USER TO "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT", TO REFRAIN FROM USING THE CHAMBER IF IT HAS BEEN DROPPED AND "TO SET THE APPROPRIATE VENTILATOR ALARMS" IN THE EVENT A LEAK OCCURS. FISHER & PAYKEL HEALTHCARE REQUESTED THE VENTILATOR SETTINGS, HOWEVER THE DISTRIBUTOR ADVISED THAT THE HOSPITAL DID NOT WANT TO PROVIDE ANY ADDITONAL INFORMATION. WITHOUT INFORMATION REGARDING THE USAGE OF THE CHAMBERS, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE CRACKS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THREE (3) MR290 AUTOFILL HUMIDIFICATION CHAMBERS CRACKED AFTER SEVERAL HOURS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THREE (3) MR290 AUTOFILL HUMIDIFICATION CHAMBERS CRACKED AFTER SEVERAL HOURS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 091004

    Patients

    Seq Age Sex Outcome Treatment
    1 INFANT FLOW SIPAP| INFANT FLOW SIPAP