BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IE33 ULTRASOUND MACHINE

    MDR report key: 2771416 · Received September 13, 2012

    Report

    Report Number
    2771416
    Event Type
    Malfunction
    Date Received
    September 13, 2012
    Date of Event
    August 18, 2012
    Report Date
    September 13, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A TTE (TRANS THORACIC ECHOCARDIOGRAM) PERFORMED WITH ULTRASOUND MACHINE. THE MACHINE WOULD NOT TURN ON AFTER STUDY WAS DONE. THE TTE WAS UNABLE TO BE RETRIEVED. PATIENT HAD TO HAVE ANOTHER ONE PERFORMED THE NEXT DAY. SERVICE ENGINEER FROM PHILIPS MEDICAL WAS CONTACTED AND REPORTED THAT, AFTER SEVERAL ATTEMPTS, THE FILES WERE CORRUPT AND NO PATIENT EXAMS COULD BE RETRIEVED.MANUFACTURER RESPONSE FOR ULTRASOUND MACHINE, IE33 ULTRASOUND MACHINE (PER SITE REPORTER):THEY ATTEMPTED TO RETRIEVE THE IMAGES BUT SAID IT WAS CORRUPT AND TWO PATIENTS HAD TO HAVE THEIR STUDIES REDONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IE33 ULTRASOUND MACHINE SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO PHILIPS MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR