BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIIC IX UPGRADE PIIC

    MDR report key: 3815448 · Received May 7, 2014

    Report

    Report Number
    1218950-2014-02590
    Event Type
    Death
    Date Received
    May 7, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 22, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT EXPIRED AND THAT THE ALARM VOLUME AT THE CENTRAL WAS TOO LOW TO BE HEARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276702 PIIC IX UPGRADE PIIC MHX PHILIPS MEDICAL SYSTEMS 866117

    Patients

    Seq Age Sex Outcome Treatment
    1 Death