BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEPSTYLE AUTO

    MDR report key: 20689797 · Received November 14, 2024

    Report

    Report Number
    9611451-2024-00779
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Report Date
    October 17, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZD
    UDI-DI
    09420012437068
    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: FISHER & PAYKEL HEALTHCARE REQUESTED THE COMPLAINT SLEEPSTYLE AUTO CPAP FOR EVALUATION BUT WAS NOT RETURNED. OUR INVESTIGATION IS BASED ON THE INFORMATION, INCLUDING PHOTOGRAPHS, PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCT. RESULT: REVIEW OF THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER SHOWED A BROKEN AND DISLODGED POWER SOCKET OF A SLEEPSTYLE AUTO CPAP. CONCLUSION: WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. OUR USER INSTRUCTIONS THAT ACCOMPANY THE SLEEPSTYLE AUTO CPAP 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. SPSAAN 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 DISTRIBUTOR IN CANADA REPORTED THAT THE SLEEPSTYLE CPAP HAS BROKEN POWER CONNECTION AND THE MACHINE TURNS OFF DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351512 SLEEPSTYLE AUTO CPAP BZD FISHER & PAYKEL HEALTHCARE LTD SPSAAN 2100924094 09420012437068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown