BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAIN PCB (ASTRAL 150) - 90HPA

    MDR report key: 10788909 · Received November 4, 2020

    Report

    Report Number
    3004604967-2020-01048
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    August 6, 2020
    Report Date
    April 20, 2021
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    UDI-DI
    00619498290529
    PMA / PMN Number
    K152068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED ON ALL AVAILABLE INFORMATION. BASED ON ALL AVAILABLE EVIDENCE, THE INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT WAS DUE TO OPERATOR ERROR. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE#: PR 2123903.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE MAIN CIRCUIT BOARD FAILED DURING TESTING BY THE CUSTOMER. THE DEVICE WAS NOT IN PATIENT USE WHEN THE REPORTED EVENT OCCURRED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION WAS PERFORMED. THE REPORTED FAILURE COULD NOT BE REPRODUCED DURING EVALUATION AND THE DEVICE OPERATED PER SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE MAIN CIRCUIT BOARD FAILED DURING TESTING BY THE CUSTOMER. THE DEVICE WAS NOT IN PATIENT USE WHEN THE REPORTED EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254332 MAIN PCB (ASTRAL 150) - 90HPA CBK RESMED LTD 29052 1446525 00619498290529

    Patients

    Seq Age Sex Outcome Treatment
    1