BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS SUPPLY LINE 2.1MT

    MDR report key: 2040493 · Received April 6, 2011

    Report

    Report Number
    9611451-2011-00217
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Report Date
    March 7, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION WITH REGARD TO THIS COMPLAINT. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE TWO RETURNED COMPLAINT BC400 GAS SUPPLY LINES WERE OCCLUDED AT ONE CONNECTOR END AND SUBMERGED IN A WATERBATH TO TEST FOR LEAKS. THE WATERBATH TEST WAS REPEATED BY OCCLUDING THE OTHER CONNECTOR END. RESULTS: THE WATERBATH TEST DID NOT REVEAL ANY LEAKAGE FOR BOTH RETURNED COMPLAINT SUPPLY LINES. NO LOT CHECK COULD BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: NO FAULT WAS FOUND WITH TWO RETURNED COMPLAINT GAS SUPPLY LINES.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS AIR LEAKING AROUND THE ADAPTOR OF AN BC400 GAS SUPPLY LINE DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS AIR LEAKING AROUND THE ADAPTOR OF AN BC400 GAS SUPPLY LINE DURING USE.NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAS SUPPLY LINE 2.1MT BZO BZO FISHER & PAYKEL HEALTHCARE LTD BC400-10

    Patients

    Seq Age Sex Outcome Treatment
    1