BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADULT VENTILATOR DUAL HEATED CIRCUIT KIT

    MDR report key: 16950879 · Received May 17, 2023

    Report

    Report Number
    9611451-2023-00455
    Event Type
    Injury
    Date Received
    May 17, 2023
    Date of Event
    April 12, 2023
    Report Date
    April 18, 2023
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K122432. FISHER AND PAYKEL HEALTHCARE (F&P) ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION REGARDING THE REPORTED EVENT. WE HAVE ALSO REQUESTED THE RETURN OF THE SUBJECT 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT TO F&P NEW ZEALAND FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K122432. METHOD: THE COMPLAINT 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) NEW ZEALAND, WHERE VISUAL INSPECTION AND PERFORMANCE TESTING WAS CARRIED OUT. ADDITIONALLY TESTING WAS CONDUCTED IN AN ATTEMPT TO REPLICATE THE REPORTED EVENT. RESULTS: VISUAL INSPECTION OF THE RETURNED CIRCUIT KIT DID NOT FIND ANY DEFECTS OR DEFORMITIES. THE RETURNED CIRCUIT KIT PASSED GAS LEAKAGE TESTING. IT WAS ONLY POSSIBLE TO REPLICATE THE TUBING COLLAPSE DESCRIBED BY THE HEALTHCARE FACILITY BY APPLYING EXTREME CONDITIONS THAT INVOLVED HIGH SUCTION PRESSURE, A COMPLETELY OCCLUDED CIRCUIT AND SUCTION APPLIED FOR A SUSTAINED PERIOD. THESE CONDITIONS ARE NOT ANTICIPATED IN COMMONLY ACCEPTED CLINICAL USE. CONCLUSION: IN THE TESTING CARRIED OUT, TUBE COLLAPSE OF THE RETURNED CIRCUIT WAS ONLY REPLICATED UNDER EXTREME CONDITIONS (HIGH PRESSURE, LONG DURATION, AND OCCLUSION). STANDARD CLINICAL PRACTICE IS TO AVOID HIGH SUCTION PRESSURE FOR A SUSTAINED PERIOD WHEN SUCTIONING. ADDITIONALLY, THE TESTING ILLUSTRATED THAT THERE WOULD NEED TO HAVE BEEN AN OCCLUSION WITHIN THE WIDER BREATHING CIRCUIT SYSTEM FOR COLLAPSE TO HAVE OCCURED. THE INVESTIGATION CONFIRMED THAT THERE WERE NO FAULTS FOUND WITH THE RETURNED CIRCUIT KIT. BASED ON THE RESULTS OF THE INVESTIGATION, IT WOULD NOT BE EXPECTED THAT THE EXPIRATORY TUBE COULD COLLAPSE WITH SUCTIONING ALONE. THE CAUSE OF THE REPORTED FAULT REMAINS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN VANCOUVER REPORTED ON 18 APRIL 2023, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT ON (B)(6) 2023 THE EXPIRATORY LIMB OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT COLLAPSED DURING USE. THIS WAS NOTICED AFTER THE PATIENT DESATURATED TO 60% SPO2. THE CIRCUIT WAS IMMEDIATELY MANIPULATED BACK INTO SHAPE BY A RESPIRATORY THERAPIST AND THE PATIENT'S SPO2 RECOVERED. ON 9 MAY 2023, THE HEALTHCARE FACILITY IN VANCOUVER FURTHER REPORTED, VIA A F&P REP, THAT THERE WAS A SECOND EVENT WHERE THE EXPIRATORY LIMB OF THE SUBJECT 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT COLLAPSED DURING USE WHICH OCCURRED ON (B)(6) 2023. IT WAS REPORTED THAT THE NURSE ON SHIFT AT THE TIME SAW THE EXPIRATORY LIMB OF THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT COLLAPSE AND IMMEDIATELY MANIPULATED THE EXPIRATORY LIMB BACK INTO SHAPE. IT WAS REPORTED BY THE HEALTHCARE FACILITY THAT THERE WERE NO PATIENT CONSEQUENCES ASSOCIATED WITH THE SECOND EVENT. IT WAS ALSO REPORTED ON 9 MAY 2023 THAT THE PATIENT HAS SINCE PASSED AWAY. THE HEALTHCARE FACILITY STATED THAT THERE WAS NO RELATIONSHIP BETWEEN THE REPORTED INCIDENT AND THE PATIENT'S DEATH. F&P ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION ABOUT THE REPORTED EVENT INCLUDING FURTHER INFORMATION ABOUT THE MEDICAL CAUSE OF DEATH.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN VANCOUVER REPORTED ON (B)(6) 2023, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT ON (B)(6) 2023 THE EXPIRATORY LIMB OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT COLLAPSED DURING USE. THIS WAS NOTICED AFTER THE PATIENT DESATURATED TO 60% SPO2. THE CIRCUIT WAS IMMEDIATELY MANIPULATED BACK INTO SHAPE BY A RESPIRATORY THERAPIST AND THE PATIENT'S SPO2 RECOVERED. ON (B)(6) 2023, THE HEALTHCARE FACILITY IN VANCOUVER FURTHER REPORTED, VIA A F&P REP, THAT THERE WAS A SECOND EVENT INVOLVING THE SAME PATIENT WHERE THE EXPIRATORY LIMB OF THE SUBJECT 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT COLLAPSED DURING USE WHICH OCCURRED ON (B)(6) 2023. IT WAS REPORTED THAT THE NURSE ON SHIFT AT THE TIME SAW THE EXPIRATORY LIMB OF THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT COLLAPSE AND IMMEDIATELY MANIPULATED THE EXPIRATORY LIMB BACK INTO SHAPE. IT WAS REPORTED BY THE HEALTHCARE FACILITY THAT THERE WERE NO PATIENT CONSEQUENCES ASSOCIATED WITH THE SECOND EVENT. IT WAS ALSO REPORTED ON (B)(6) 2023 THAT THE PATIENT HAS SINCE PASSED AWAY. THE HEALTHCARE FACILITY STATED THAT THERE WAS NO RELATIONSHIP BETWEEN THE REPORTED INCIDENT AND THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440086 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD 950A81

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Life Threatening