BEUDAMED
    FDA Adverse Event Death Summary report: N

    IU22 ULTRASOUND SYSTEM

    MDR report key: 3780748 · Received April 17, 2014

    Report

    Report Number
    1218950-2014-01946
    Event Type
    Death
    Date Received
    April 17, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    PMA / PMN Number
    K042540
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IU22 ULTRASOUND SYSTEM WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER AND CUSTOMER SITE CLINICAL PERSONNEL. THE IU22 ULTRASOUND SYSTEM WAS CONFIRMED TO BE FUNCTIONING NORMALLY. A MEDICAL PROFESSIONAL FROM THE HEALTHCARE FACILITY CONFIRMED THERE WAS NO CAUSAL CORRELATION BETWEEN THE LOSS OF PREGNANCY AND THE IU22 ULTRASOUND SYSTEM.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THE HEART RATE CALCULATED BY THE IU22 ULTRASOUND SYSTEM ON A PEDIATRIC PT DID NOT MATCH THE PT HEART RATE SHOWN ON THE DISPLAYED IMAGE. THE CUSTOMER LATER CONFIRMED THE IU22 ULTRASOUND SYSTEM DID NOT MALFUNCTION. THE CUSTOMER REPORTED A TERMINATION IN THE PREGNANCY PRIOR TO THE ULTRASOUND TAKING PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236115 IU22 ULTRASOUND SYSTEM IYO IYN ITX IYO PHILIPS ULTRASOUND, INC. 795050 B03Y2L

    Patients

    Seq Age Sex Outcome Treatment
    1 Death