BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEPSTYLE AUTO

    MDR report key: 20205880 · Received September 12, 2024

    Report

    Report Number
    9611451-2024-00648
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Report Date
    August 15, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZD
    UDI-DI
    09420012437259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). METHOD: THE COMPLAINT SLEEPSTYLE CPAP WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE SLEEPSTYLE CPAP CONFIRMED THAT ONE OF THE PINS WAS MISSING FROM THE MAINS INLET SOCKET (POWER SOCKET). CONCLUSION: THE REPORTED EVENT WAS TRACED TO AN ISSUE IN THE ASSEMBLY PROCESS OF THE SUPPLIED MAINS INLET CONNECTOR COMPONENT.THE COMPONENT SUPPLIER HAS SINCE IMPLEMENTED CHANGES TO THE ASSEMBLY PROCESS AND F&P HEALTHCARE ALSO INTRODUCED A GAUGE TEST TO IDENTIFY AND REJECT ANY POTENTIALLY FAULTY MAINS INLET SOCKETS DURING THE ASSEMBLY OF THE SLEEPSTYLE DEVICES. OUR INVESTIGATION CONFIRMED THAT THE SUBJECT SLEEPSTYLE DEVICE WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THESE MEASURES. OUR USER INSTRUCTIONS THAT ACCOMPANY THE F&P SLEEPSTYLE STATE THE FOLLOWING: "DO NOT USE IF THE DEVICE, POWER CORD, OR ACCESSORIES ARE DAMAGED, DEFORMED OR CRACKED". "DO NOT PULL ON THE POWER CORD AS IT MAY BECOME DAMAGED". "TURN THE DEVICE OFF AT THE POWER SUPPLY, THEN REMOVE THE POWER CORD FROM THE REAR OF THE DEVICE". SPSABN 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 K173193.

    Additional Manufacturer Narrative · 0

    (B)(4). FISHER & PAYKEL HEALTHCARE (F&P) HAVE REQUESTED FOR THE RETURN OF THE SUBJECT SLEEPSTYLE TO F&P NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION. SPSABN 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 K173193.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN CANADA REPORTED THAT ONE OF THE CONNECTION PINS AT THE BACK OF A SLEEPSTYLE CPAP IS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN CANADA REPORTED THAT ONE OF THE CONNECTION PINS AT THE BACK OF A SLEEPSTYLE CPAP IS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575611 SLEEPSTYLE AUTO CPAP BZD FISHER & PAYKEL HEALTHCARE LTD SPSABN 2100527409 09420012437259

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown