BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEPSTYLE AUTO

    MDR report key: 21063343 · Received January 2, 2025

    Report

    Report Number
    9611451-2024-00952
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    September 5, 2024
    Report Date
    December 5, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZD
    UDI-DI
    09420012445650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    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 THE MAINS INLET SOCKET (POWER SOCKET) HOUSING WAS DAMAGED. THE ELECTRICAL PINS WERE NOT DAMAGED. CONCLUSION: WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. 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". SPSAAJ 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. SPSAAJ 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 JAPAN REPORTED THAT THE SLEEPSTYLE AUTO HAS A DAMAGED ELECTRICAL SOCKET. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN JAPAN REPORTED THAT THE SLEEPSTYLE AUTO HAS A DAMAGED ELECTRICAL SOCKET. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599972 SLEEPSTYLE AUTO CPAP BZD FISHER & PAYKEL HEALTHCARE LTD SPSAAJ 2101708382 09420012445650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown