BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 20072768 · Received August 26, 2024

    Report

    Report Number
    9611451-2024-00620
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 12, 2024
    Report Date
    July 29, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    UDI-DI
    09420012436825
    PMA / PMN Number
    K220703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: PMA/510(K) NUMBER - THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (WITH FILTER) IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT INSTEAD A SIMILAR PRODUCT, 950A81J ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (WITH FILTER) IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K220703. FISHER & PAYKEL HEALTHCARE (F&P) HAS REQUESTED THE RETURN OF THE SUBJECT 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (WITH FILTER) 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). SECTION G4: PMA/510(K) NUMBER - THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (WITH FILTER) IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT INSTEAD A SIMILAR PRODUCT, 950A81J ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (WITH FILTER) IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K220703. METHOD: THE COMPLAINT DEVICE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (WITH FILTER) WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) NEW ZEALAND, WHERE IT WAS VISUALLY INSPECTED AND TESTED. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, EVALUATION OF THE RETURNED DEVICE AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION CONFIRMED THAT THE RETURN DEVICE WAS IN GOOD CONDITION. GAS LEAKAGE TESTS WERE CARRIED OUT AND THE OBSERVED LEAKAGE WAS IN SPECIFICATIONS AS PER USER INSTRUCTIONS. THE COMPLAINT DEVICE HAS PASSED THE PERFORMANCE TESTING, AND NO ALARM COULD BE OBSERVED. THE RETURNED DEVICE, 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (WITH FILTER) WAS FUNCTIONING AS INTENDED. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FAULT AS THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. ALL 950A81 ADULT VENTILATOR DUAL HEATED BREATHING CIRCUITS ARE 100% LEAK TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE USER INSTRUCTIONS WHICH ACCOMPANY THE 950A81 ADULT VENTED DUAL HEATED CIRCUIT KIT STATE 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. DO NOT CRUSH, STRETCH, OR MILK THE TUBING. PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN DENMARK HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT DURING VENTILATION SETUP, TWO OF THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KITS (WITH FILTER) WERE LEAKING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN DENMARK HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT DURING VENTILATION SETUP, TWO OF THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KITS (WITH FILTER) WITH SAME BATCH DETAILS FAILED THE LEAK TEST. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969101 FISHER & PAYKEL HEALTHCARE HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT FISHER & PAYKEL HEALTHCARE LTD 950A81 2102215352 09420012436825

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NON F&P VENTILATOR.