BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE CPAP CIRCUIT

    MDR report key: 2061711 · Received April 19, 2011

    Report

    Report Number
    9611451-2011-00247
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Report Date
    March 23, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZD
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): THE BC151 IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K100011. METHOD: THE RETURNED BC151 BUBBLE CPAP CIRCUIT KIT WAS VISUALLY INSPECTED FOR A MISSING INSPIRATORY TUBE. RESULTS: THE REPORTED FAULT WAS CONFIRMED. THE INSPIRATORY TUBE WAS MISSING FROM THE RETURNED BC151 KIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110126. 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 INSPIRATORY TUBE BEING OMITTED FROM THE CIRCUIT KIT. THE 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. THE BUBBLE CPAP CIRCUIT KITS ARE VISUALLY INSPECTED FOR MISSING COMPONENTS PRIOR TO DISTRIBUTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE INSPIRATORY TUBE WAS MISSING FROM A BC151 BUBBLE CPAP CIRCUIT KIT. THIS WAS NOTICED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUBBLE CPAP CIRCUIT BZD BZD FISHER & PAYKEL HEALTHCARE LIMITED BC151 110126

    Patients

    Seq Age Sex Outcome Treatment
    1