BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE CPAP SYSTEM

    MDR report key: 2829437 · Received November 12, 2012

    Report

    Report Number
    9611451-2012-00810
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 19, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZD
    PMA / PMN Number
    K100011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT BC151 BUBBLE CPAP SYSTEM KIT WAS RECEIVED IN AN UNSEALED BAG AND WAS VISUALLY INSPECTED FOR A MISSING BLUE EXTENSION TUBE. RESULTS: THE INSPIRATORY EXTENSION TUBE WAS MISSING FROM THE KIT, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120808. CONCLUSION: THE BUBBLE CPAP CIRCUIT KIT CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. IT IS LIKELY THAT OPERATOR ERROR, DURING THE PACKING PROCESS, RESULTED IN THE TUBE BEING OMITTED FROM THE BUBBLE CPAP SYSTEM KIT. NEW STANDARD OPERATING PROCEDURES HAVE BEEN PUT IN PLACE TO ASSIST THE OPERATORS ON THE PRODUCTION LINE TO CORRECTLY PACK THE CIRCUIT KITS. A SPECIFIC PACK CARD DETAILING ALL COMPONENTS REQUIRED MUST BE DISPLAYED AT THE PACKING STATION. IN ADDITION, THE BUBBLE CPAP SYSTEM KITS ARE VISUALLY INSPECTED FOR MISSING COMPONENTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A BLUE EXTENSION TUBE WAS MISSING FROM A BC151 BUBBLE CPAP SYSTEM KIT. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUBBLE CPAP SYSTEM BZD BZD FISHER & PAYKEL HEALTHCARE LIMITED BC151 120808

    Patients

    Seq Age Sex Outcome Treatment
    1