BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHAMBER COMPLETE AUTOFEED 900

    MDR report key: 9614209 · Received January 21, 2020

    Report

    Report Number
    9611451-2020-00059
    Event Type
    Malfunction
    Date Received
    January 21, 2020
    Report Date
    December 23, 2019
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE Z41002 CHAMBER COMPLETE AUTOFEED 900 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 K934140. METHOD: THE COMPLAINT Z41002 CHAMBER COMPLETE AUTOFEED 900 WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION AND PHOTOGRAPH PROVIDED BY THE CUSTOMER. RESULTS: THE CUSTOMER REPORTED THAT THE Z41002 CHAMBER COMPLETE AUTOFEED 900 WAS TRIGGERING LOW TEMPERATURE ALARMS. A VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPH REVEALED THAT THE WATER WAS ABOVE THE WATER LINE IN THE CHAMBER. CONCLUSION: WITHOUT THE RETURN OF THE COMPLAINT DEVICE OR WITH THE INFORMATION PROVIDED FROM THE CUSTOMER, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FAULT. FROM THE PROVIDED PHOTO, IT WAS LIKELY DETERMINED THAT THE PRIMARY VALVE MECHANISM IN THE Z41002 CHAMBER WAS DISABLED, LEADING TO WATER BEING ABOVE THE BLACK WATER LEVEL LINE ON THE CHAMBER. IN THIS INSTANCE, THE SECONDARY FLOAT WILL SERVE AS A BACKUP TO PREVENT THE WATER FROM OVERFLOWING OUTSIDE THE CHAMBER PORT AND ENTERING INTO THE BREATHING CIRCUIT. ALL Z41002 CHAMBERS HAVE FLOAT FUNCTION AND VALVE TESTING PERFORMED TWICE DURING PRODUCTION. A FAILURE OF ANY TEST WOULD RESULT IN REJECTION OF THE CHAMBER BEFORE DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE Z41002 CHAMBER COMPLETE AUTOFEED 900 SPECIFY IN THE WARNING SECTION "DO NOT USE THE CHAMBER IF THE WATER RISES ABOVE THE MAXIMUM WATER LEVEL LINE" ALONG WITH A DIAGRAM DIRECTING THE USER TO CHECK THE WATER LEVEL ON THE CHAMBER. A WRITTEN DESCRIPTION OF THE MEANING OF THE SYMBOLS USED IS ALSO INCLUDED IN THE USER INSTRUCTIONS. IT ALSO STATES THE FOLLOWING: - "SET APPROPRIATE VENTILATOR ALARM." - "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN AUSTRALIA REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT THE Z41002 CHAMBER COMPLETE AUTOFEED 900 WAS TRIGGERING LOW TEMPERATURE ALARMS. UPON ASSESSMENT OF THE PROVIDED PHOTOGRAPH FROM THE CUSTOMER, THE DEVICE WAS FOUND WITH THE WATER BEING ABOVE THE WATER LINE IN THE CHAMBER. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE Z41002 CHAMBER COMPLETE AUTOFEED 900 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 K934140. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION TO DETERMINE IF THE COMPLAINT Z41002 CHAMBER COMPLETE AUTOFEED 900 CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT THE Z41002 CHAMBER COMPLETE AUTOFEED 900 WAS TRIGGERING LOW TEMPERATURE ALARMS. UPON ASSESSMENT OF THE PROVIDED PHOTOGRAPH FROM THE CUSTOMER, THE DEVICE WAS FOUND WITH THE WATER BEING ABOVE THE WATER LINE IN THE CHAMBER. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77165 CHAMBER COMPLETE AUTOFEED 900 AUTOFEED CHAMBER BTT Z41002 190903

    Patients

    Seq Age Sex Outcome Treatment
    1