BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DALCON ALERT

    MDR report key: 7100279 · Received December 8, 2017

    Report

    Report Number
    3009164985-2017-00001
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    October 16, 2014
    Report Date
    December 7, 2017
    Manufacturer
    AMPLION CLINICAL COMMUNICATIONS
    Product Code
    ILQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUPPORT ANALYST SPOKE WITH THE SITE WHO REPORTED A PATIENT CODED AT 17:32 HOURS THE NIGHT BEFORE. THEY ALLEGED THEY HAD AN ISSUE WITH A VENT ALERT MESSAGE NOT GOING TO ONE OF THE NURSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881460 DALCON ALERT DALCON ALERT;REMOTE ALERT MONITORING ILQ AMPLION CLINICAL COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 HR Life Threatening