BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9611451-2007-00242

    MDR report key: 868678 · Received June 22, 2007

    Report

    Report Number
    9611451-2007-00242
    Event Type
    Malfunction
    Date Received
    June 22, 2007
    Date of Event
    November 20, 2006
    Report Date
    November 29, 2006
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    PMA / PMN Number
    K0304026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE RETURNED DEVICE WAS VISUALLY INSPECTED AND DIGITAL IMAGES WERE TAKEN. RESULTS: THE MESH WAS CUT BACK AND MARKED APPROX 200 MM FROM THE PT END. THERE WAS A SMALL HOLE OBSERVED (APPROX 4 MM IN LENGTH) IN THE THIN FILM NEXT TO A BEAD. THE BEAD WAS DISTORTED SIDEWAYS FROM THE NORMAL SPIRAL PATTERN AND THE FILM AROUND THE HOLE HAD BEEN STRETCHED. THERE WAS ANOTHER DAMAGED AREA APPROX 500 MM FROM THE ELBOW END, WHERE THE FILM IN THIS ZONE HAD BEEN STRETCHED AND SOME OF THE SPIRALS OF THE BEAD WERE SQUASHED ENOUGH TO KINK THEM AND MAKE THEM OVAL SHAPED. THERE WAS NO TEAR OBSERVED IN THIS REGION - THERE ARE ALSO TWO REGIONS OF CREASE-LIKE MARKS IN THE FILM, THEY OCCUR AT APPROX 250 MM AND 450 MM FROM THE PT END. BOTH REGIONS LINE UP WITH EACH OTHER. THE MARKS ARE ANGLED COMPARED TO THE BEAD. CONCLUSIONS: THE DAMAGE OBSERVED TO THE CIRCUIT WAS MOST LIKELY CAUSED BY A CIRCUIT HANGER/HOLDER. WE ARE AWARE OF OTHER SIMILAR COMPLAINTS INVOLVING THE INFANT EVAQUA EXPIRATORY LIMB. THE OCCURRENCE RATE OF THIS TYPE OF COMPLAINT IS APPROX 0.023% WORLDWIDE FOR THE LAST YEAR. WE HAVE AN OPEN CAPA ITEM TO ADDRESS SUCH COMPLAINTS AND PUT MEASURES IN PLACE TO REDUCE AND/OR PREVENT RECURRENCE. PLEASE NOTE, THIS REPORT WAS INADVERTENTLY OMITTED FROM A RETROSPECTIVE SUMMARY REPORT, REFERENCE 9611451-2007-00013, PRODUCT CODE BZE. AS MENTIONED IN FOLLOW-UP # 4 FOR MDR 9611451-2006-00007, WE ARE SUBMITTING THIS REPORT FOLLOWING OUR DISCOVERY OF THIS OMISSION.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED, THAT AN RT236 BREATHING CIRCUIT FAILED THE LEAK TEST ON THE MAQUET "I" VENTILATOR DURING THE SETUP PROCESS. THE DEVICE WAS NOT USED ON A PT DURING THE SET UP PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BZE FISHER & PAYKEL HEALTHCARE, LTD. RT236 060914

    Patients

    Seq Age Sex Outcome Treatment
    1 YR MAQUET SERVO I VENTILATOR