BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1619182 · Received February 24, 2010

    Report

    Report Number
    9611451-2010-00092
    Event Type
    Malfunction
    Date Received
    February 24, 2010
    Date of Event
    January 25, 2010
    Report Date
    January 25, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED CHAMBER WAS VISUALLY INSPECTED FOR EVIDENCE OF A DETACHED SPIKE AND/OR BROKEN TUBE. RESULTS: OUR EXAMINATION OF THE DEVICE CONFIRMED THAT THE VENT SPIKE HAD PARTED FROM THE WATER FEEDSET TUBING, JUST SHORT OF WHERE BOTH COMPONENTS CONNECT TO EACH OTHER. THE RIM OF THE TUBING APPEARED TO BE ROUGH WITH VISIBLE TRACK MARKS, CONSISTENT WITH A TEAR OR PULL. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE, FOR ANY COUNTRY WORLDWIDE, FOR THE LOT NUMBER PROVIDED (091126). CONCLUSION/COMMENTS: IT IS LIKELY THAT THE WATER FEEDSET TUBING BROKE AWAY FROM THE VENT SPIKE AS A RESULT OF SUBSTANTIAL FORCE APPLIED TO IT, FOR INSTANCE IF ACCIDENTALLY PULLED OR STRETCHED. THIS IS CONSISTENT WITH THE HOSPITAL'S REPORT THAT THE DAMAGE OCCURRED AT THE TIME THE WATERBAG WAS BEING CHANGED. AS PART OF OUR MANUFACTURING PROCESS, EVERY MR290V CHAMBER UNDERGOES PRESSURE TESTING FOR POTENTIAL LEAKS. HAD THE FEEDSET TUBING BEEN DAMAGED IN SUCH A MANNER AT THE TIME OF PRODUCTION, THE CHAMBER WOULD NOT HAVE PASSED THE FINAL PRESSURE TEST AND BEEN REJECTED. OUR USER INSTRUCTIONS WHICH ACCOMPANIES THE MR290 CHAMBER SPECIFIES THE IMPORTANCE OF PERFORMING A PRESSURE/LEAK TEST ON THE SYSTEM PRIOR TO PATIENT CONNECTION. THE INSTRUCTIONS ALSO REMIND THE USER TO SET THE APPROPRIATE VENTILATOR ALARMS TO ALERT ATTENDING HOSPITAL STAFF IN THE EVENT THAT A LEAK IN THE SYSTEM DEVELOPS DURING USE. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) ('THE HOSPITAL') REPORTED TO A FISHER & PAYKEL HEALTHCARE ('FPH') FIELD REPRESENTATIVE THAT THE WATERFEED SET TUBING OF AN MR290V AUTOFEED HUMIDIFICATION CHAMBER ('THE CHAMBER') BROKE OFF IN THE REGION WHERE IT CONNECTED TO THE CHAMBER'S VENT SPIKE. THE HOSPITAL FURTHER ADVISED FPH THAT THE BREAKAGE OCCURRED AT THE TIME THE WATERBAG WAS BEING CHANGED, PROBABLY AS THE VENT SPIKE WAS BEING PULLED FROM THE WATER BAG. THE HOSPITAL ALSO CONFIRMED THAT NEITHER THE PATIENT NOR ATTEMPTING HOSPITAL STAFF AND/OR CAREGIVER(S) SUSTAINED ANY INJURY OR OTHER CONSEQUENCE AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 091126

    Patients

    Seq Age Sex Outcome Treatment
    1