BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER FEEDSET

    MDR report key: 3090857 · Received May 2, 2013

    Report

    Report Number
    9611451-2013-00350
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 4, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAW
    PMA / PMN Number
    K953949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE AS IT WAS DISCARDED BY THE HOSPITAL. OUR EVALUATION IS BASED ON OUR KNOWLEDGE OF THE PRODUCT AND THE INFORMATION PROVIDED BY THE CUSTOMER. WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO CONFIRM THE REPORTED FAULT AND DETERMINE THE CAUSE OF THE REPORTED EVENT. THE FUNCTION OF THE SPRING ON THE 900MR190 WATER FEEDSET IS CHECKED DURING PRODUCTION. A LEAK TEST IS ALSO PERFORMED ON THE 900MR190 WATER FEEDSET. THIS SUGGESTS THAT THE COMPLAINT 900MR190 DEVICE WAS WITHIN SPECIFICATION PRIOR TO BEING RELEASED FOR DISTRIBUTION. THE 900MR190 WATER FEEDSET DEVICE IS EXPECTED TO FUNCTION CORRECTLY IF THE USER INSTRUCTIONS ARE FOLLOWED CORRECTLY. IT IS POSSIBLE THAT THE USER INSTRUCTIONS FOR THE 900MR190 DEVICE WERE NOT FOLLOWED CORRECTLY. THE USER INSTRUCTIONS STATE THE FOLLOWING: "SQUEEZE THE CLAMP ALLOWING THE SOLUTION TO ENTER THE RESPIRATORY DEVICE. FILL TO THE MAXIMUM WATER LEVEL PRESCRIBED FOR THE DEVICE." "DO NOT OVERFILL." "RELEASE THE CLAMP TO THE CLOSED POSITION. ENSURE WATER FLOW HAS STOPPED." (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AS IT IS NOT AVAILABLE. OUR INVESTIGATION IS CURRENTLY IN PROGRESS AS WE ARE OBTAINING FURTHER INFORMATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A WATER LEAK OCCURRED AT THE CUT OFF SWITCH OF THE 900MR190 WATER FEEDSET. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT A WATER LEAK OCCURRED AT THE CUT OFF SWITCH OF THE 900MR190 WATER FEEDSET. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192502 WATER FEEDSET CAW CAW FISHER & PAYKEL HEALTHCARE LTD 900MR190

    Patients

    Seq Age Sex Outcome Treatment
    1