BEUDAMED
    FDA Adverse Event Other Summary report: N

    VPAP III QUICKLY - EUR GP2

    MDR report key: 3542376 · Received December 23, 2013

    Report

    Report Number
    3004604967-2013-00040
    Event Type
    Other
    Date Received
    December 23, 2013
    Date of Event
    November 16, 2013
    Report Date
    November 28, 2013
    Manufacturer
    RESMED LTD.
    Product Code
    MNS
    PMA / PMN Number
    K060105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT TO (B)(4) FOR AN ENGINEERING INVESTIGATION. THE ENGINEERING INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED COMPLAINT AS A FAILURE OF THE MAIN PCBA. RESMED HAS CONDUCTED STATISTICAL ANALYSIS OF THE FIELD RETURN DATA FOR THIS FAILURE MADE ALONG WITH PERFORMING A SAFETY RISK ANALYSIS AND CONCLUDED THAT THE RISK IS ACCEPTABLE. THERE WAS NO ADVERSE EVENT REPORTED AND NO INCIDENT OF HARM TO PATIENT.

    Description of Event or Problem · 1

    RESMED (B)(4) WAS MADE AWARE THAT A VPAP DEVICE TURNED OFF BY ITSELF WHILE A PATIENT WAS RECEIVING THERAPY. THE PATIENT WAS ABLE TO GET HIS PARENTS ATTENTION AND THERAPY WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672506 VPAP III QUICKLY - EUR GP2 MNS RESMED LTD. 24135

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention