BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2070084 · Received April 26, 2011

    Report

    Report Number
    9611451-2011-00268
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 30, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED BY FPH (B)(4) TO FPH (B)(4) FOR FURTHER INVESTIGATION, HOWEVER, IT WAS LOST DURING TRANSIT. WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE THE POSSIBLE ROOT CAUSE OF THE REPORTED FAULT. AS ALL MR290 CHAMBERS ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE, THIS SUGGESTS THE SUBJECT CHAMBER WAS DAMAGED POST PRODUCTION. THE MR290 USER INSTRUCTIONS PROVIDE THE FOLLOWING WARNINGS: "DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IT HAS BEEN DROPPED". "SET APPROPRIATE VENTILATOR ALARM". -"PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT".

    Additional Manufacturer Narrative · 1

    (B)(4). THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED TO FISHER & PAYKEL HEALTHCARE (FPH) SERVICE ENGINEER THAT THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS BROKEN. THIS WAS OBSERVED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS BROKEN. THIS WAS OBSERVED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 100906

    Patients

    Seq Age Sex Outcome Treatment
    1