BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDI 5000 ULTRASOUND STANDARD SYSTEM

    MDR report key: 2517604 · Received March 30, 2012

    Report

    Report Number
    3019216-2012-00003
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Report Date
    March 22, 2012
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    PMA / PMN Number
    K961459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PHILIPS FIELD SERVICE ENGINEER WENT TO THE CUSTOMER SITE. NO INJURIES WERE REPORTED WITH THIS EVENT. THE FIELD SERVICE ENGINEER REPLACED THE PARTS AFFECTED BY THIS EVENT. THE SYSTEM WAS PUT BACK INTO SERVICE AFTER THE REPAIR. THE AFFECTED PARTS ARE IN TRANSIT BACK TO PHILIPS FOR ANALYSIS AS OF THIS MDR SUBMISSION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE NEW INFO BECOMES AVAILABLE. K991671, K002003, K011224, K034003.

    Description of Event or Problem · 1

    PHILIPS HEALTHCARE CUSTOMER SERVICE CENTER RECEIVED A CALL FROM THE CUSTOMER STATING THAT WHILE THE HDI5000 ULTRASOUND SYSTEM WAS IDLE, THE CUSTOMER NOTICED IT CAUGHT FIRE. THE CUSTOMER IMMEDIATELY EXTINGUISHED THE FIRE AND CALLED PHILIPS HEALTHCARE FOR REPAIR OF THE ULTRASOUND SYSTEM. THE ULTRASOUND SYSTEM WAS NOT BEING USED AT THE TIME OF THIS EVENT AND THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HDI 5000 ULTRASOUND STANDARD SYSTEM IYO IYN ITX IYO PHILIPS ULTRASOUND, INC. 795020

    Patients

    Seq Age Sex Outcome Treatment
    1