BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IE 33 ULTRASOUND SYSTEM

    MDR report key: 3853923 · Received April 16, 2014

    Report

    Report Number
    3019216-2014-00007
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    December 27, 2013
    Report Date
    March 21, 2014
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    PMA / PMN Number
    K030455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHILIPS RECEIVED MAUDE EVENT REPORT (MW5034518) ON 03/19/2014 AND INITIATED COMPLAINT (B)(4). UPON INVESTIGATION, THE RISK MANAGER, FROM THE CUSTOMER SIGHT PROVIDED INFORMATION INDICATING THE PATIENT REQUIRED ADDITIONAL ANESTHESIA DUE TO INOPERABILITY OF THE ULTRASOUND SYSTEM. NO ADVERSE EVENT OCCURRED AS A RESULT OF THE INTERRUPTION. THE FSE WENT ON SITE AND REPAIRED THE SYSTEM WITHOUT FURTHER INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PATIENT REQUIRED ADDITIONAL ANESTHESIA DURING A TEE PROCEDURE DUE TO A DAMAGED POWER CORD WHICH RENDERED THE ULTRASOUND SYSTEM AS INOPERABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233530 IE 33 ULTRASOUND SYSTEM IYO IYN ITX IYO PHILIPS ULTRASOUND, INC. 795052 03B93Y

    Patients

    Seq Age Sex Outcome Treatment
    1