BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 DBL KIT FRA

    MDR report key: 6164643 · Received December 9, 2016

    Report

    Report Number
    3004604967-2016-01334
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Report Date
    May 25, 2017
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    PMA / PMN Number
    K133868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASTRAL DEVICE WAS RETURNED TO RESMED AND EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED. INTERNAL INSPECTION OF THE DEVICE AND PNEUMATIC BLOCK REVEALED SIGNS OF WATER CONTAMINATION. BASED ON ALL AVAILABLE EVIDENCE AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, THE REPORTED SYSTEM FAULT ERROR MESSAGE (SF 101) AND SUBSEQUENT POWER FAILURE WERE MOST LIKELY DUE TO CONTAMINATION FOUND WITHIN THE DEVICE PNEUMATIC BLOCK. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. RESMED REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF101) AND SUBSEQUENTLY SHUT DOWN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF101) AND SUBSEQUENTLY SHUT DOWN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814974 ASTRAL 150 DBL KIT FRA NOU RESMED LTD 27074

    Patients

    Seq Age Sex Outcome Treatment
    1