BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 DBL KIT FRA

    MDR report key: 11635502 · Received April 8, 2021

    Report

    Report Number
    3004604967-2021-00487
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 2, 2021
    Report Date
    May 7, 2021
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    PMA / PMN Number
    K152068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASTRAL DEVICE WAS RETURNED TO RESMED FOR AN INVESTIGATION. REVIEW OF THE DEVICE DATA LOGS CONFIRMED THE REPORTED INTERNAL BATTERY DEGRADED WARNING ALARM. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS ISSUE. THE MAIN CIRCUIT BOARD WAS REPLACED AS A PRECAUTION TO ADDRESS THE LEAKY SUPER CAPACITOR. BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE INVESTIGATION DETERMINED THAT THE INTERNAL BATTERY DEGRADED WARNING ALARM WAS DUE TO THE BATTERY CONTROLLER SOFTWARE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE#: PR 2250900.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE MAIN CIRCUIT BOARD HAD A LEAKY SUPER CAPACITOR AND DISPLAYED AN INTERNAL BATTERY DEGRADED WARNING ALARM. THE DEVICE WAS NOT IN PATIENT USE WHEN THE REPORTED EVENT OCCURRED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION CONFIRMED THE COMPLAINT. THE MAIN CIRCUIT BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WILL BE SERVICED AND FULLY TESTED BEFORE RETURNING TO THE CUSTOMER. RESMED REFERENCE#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE MAIN CIRCUIT BOARD HAD A LEAKY SUPER CAPACITOR. THE DEVICE WAS NOT IN PATIENT USE WHEN THE REPORTED EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530595 ASTRAL 150 DBL KIT FRA CBK RESMED LTD 27074

    Patients

    Seq Age Sex Outcome Treatment
    1