BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 22007501 · Received May 12, 2025

    Report

    Report Number
    9611451-2025-00354
    Event Type
    Injury
    Date Received
    May 12, 2025
    Report Date
    August 22, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K220703
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). CORRECTIONS: SECTION D4: NO BATCH, UDI OR DEVICE DETAILS ARE AVAILABLE AS THE HEALTHCARE FACILITY DID NOT PROVIDE THIS. SECTION G4: 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE, USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K220703. METHOD: THE SUBJECT 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT WAS NOT RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE REPORTED INFORMATION, PHOTOGRAPHS PROVIDED BY THE HEALTHCARE FACILITY, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT DURING USE OF THE 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT, CONDENSATE ACCUMULATED WITHIN A NON-F&P INTERFACE. THE NON-F&P INTERFACE WAS DESCRIBED AS APPROXIMATELY 300MM IN LENGTH AND CONSISTED OF AN UNHEATED FINE BORE INSPIRATORY TUBE, ALONG WITH AN EXTENDED SECTION OF UNHEATED EXHALATION TUBING. CONCLUSION: THE SUBJECT DEVICE WAS NOT RETURNED TO F&P HEALTHCARE FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED CONDENSATE. IT IS NOTED THAT THE SETUP INCLUDED A NON-F&P HEALTHCARE UNHEATED TUBE CONNECTED TO THE PATIENT INTERFACE. THE USER INSTRUCTIONS WHICH ACCOMPANY THE 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT CAUTIONS THE USER OF THE FOLLOWING: - APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT (E.G. IN THE EVENT OF AN INTERRUPTION TO GAS FLOW) MAY RESULT IN SERIOUS HARM OR DEATH. - MONITOR CIRCUIT CONDENSATE TO PREVENT OCCLUSION OR BUILD-UP OF FLUID. DRAIN AS REQUIRED.

    Additional Manufacturer Narrative · 0

    (B)(6). FISHER & PAYKEL HEALTHCARE (F&P) IS IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN SCOTLAND REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE AN INCIDENT INVOLVING A NON F&P INTERFACE AND A 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT, WHERE THE PATIENT WAS REPORTED TO BE APNOEIC AND WAS REPORTED TO HAVE DESATURATED TO <10% SPO2 AND BRADYCARDIA IN THE 50S (50-59BPM), WITH CONDENSATE OBSERVED IN A NON-F&P INTERFACE AT THE TIME OF THE EVENT. THE HEALTHCARE FACILITY REPORTED THAT NASOPHARYNGEAL SUCTION WAS PERFORMED AS A RESULT OF THE REPORTED EVENT, AND THE PATIENT WAS RESUSCITATED. IT WAS FURTHER REPORTED THAT THERE WAS MINIMAL CONDENSATE IN THE SUBJECT 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT, AND THAT THE CONDENSATE WAS MAINLY IN THE UNHEATED EXHALATION TUBING OF THE NON-F&P INTERFACE. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THEY DO NOT THINK THE 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT WAS THE CAUSE OF THE REPORTED INCIDENT. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE AN INCIDENT INVOLVING A NON-F&P INTERFACE AND A 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT, WHERE THE PATIENT WAS REPORTED TO BE APNOEIC AND WAS SAID TO HAVE DESATURATED DUE TO CONDENSATE IN A NON-F&P INTERFACE. THE HEALTHCARE FACILITY REPORTED THAT NASOPHARYNGEAL SUCTION WAS PERFORMED FOLLOWING THE REPORTED EVENT, AND THE PATIENT WAS RESUSCITATED. THE PATIENT IS REPORTED TO BE INVASIVELY VENTILATED WITH THE F&P 950N82 SLE VENTILATOR CIRCUIT KIT WITH NO REPORTED CONCERNS OF CONDENSATE. F&P IS CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION ABOUT THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968104 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT KIT BTT FISHER & PAYKEL HEALTHCARE LTD 950N61

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L F&P 950 RESPIRATORY HUMIDIFIER| FABIAN ACUTRONIC VENTILATOR| VIYAIR INTERFACE