BEUDAMED
    FDA Adverse Event Death Summary report: N

    LOGIQ P9

    MDR report key: 9356923 · Received November 21, 2019

    Report

    Report Number
    9710090-2019-00004
    Event Type
    Death
    Date Received
    November 21, 2019
    Date of Event
    October 16, 2019
    Report Date
    December 19, 2019
    Manufacturer
    GE ULTRASOUND KOREA, LTD.
    Product Code
    IYN
    PMA / PMN Number
    K181783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    GEHC INVESTIGATION HAS COMPLETED. THE CUSTOMER/PHYSICIAN WAS CONTACTED, AND WHEN ASKED ABOUT THE ALLEGATION OF THE LOGIQ P9 MALFUNCTIONING AND CAUSING AND/OR CONTRIBUTING TO THE PATIENT DEATH THE PHYSICIAN SAID THE LOGIQ P9 DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. ADDITIONALLY, GEHC INVESTIGATION CONCLUDED THE LOGIQ P9 DID NOT MALFUNCTION, AND DUE TO THE LACK OF INFORMATION PROVIDED BY THE CUSTOMER THE ROOT CAUSE OF THE INABILITY TO SEND CINE IMAGES TO THEIR PACS CANNOT BE DETERMINED. GEHC BELIEVES THE MOST LIKELY CAUSE OF THE INABILITY TO SEND CINE IMAGES AT THE TIME WAS DUE TO EITHER A NETWORK AND/OR PACS ISSUE. THE CINE IMAGES WERE ABLE TO BE TRANSFERRED SUCCESSFULLY TO THEIR PACS FROM THE LOGIQ P9 ON A LATER DATE.

    Additional Manufacturer Narrative · 1

    (B)(4). LEGAL MANUFACTURER: (B)(4). GE HEALTHCAREÂS SERVICE ENGINEER SERVICED THE LOGIQ P9 AND CONCLUDED THE LOGIQ P9 MAY HAVE MALFUNCTIONED. GE HEALTHCAREÂS INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE HEALTHCARE THAT A PHYSICIAN NEEDS A SERVICE ENGINEER TO ADJUST A SETTING ON THE LOGIQ P9 ULTRASOUND SYSTEM TO SEND CINE LOOPS TO THEIR NON-GE PACS BECAUSE THEY WILL NOT LOAD ONTO THEIR PACS SYSTEM. ADDITIONALLY, THE LOGIQ P9 WAS SLOW TO SPOOL IMAGES BEFORE SENDING TO PACS, AND THE SYSTEM LOCKED UP WHILE SCANNING. THE CONSEQUENCE IS THAT A PATIENT STUDY (DIAGNOSTIC PROCEDURE) COULD NOT BE LOADED AND READ ON THEIR PACS SYSTEM. PATIENT DIED BEFORE THEIR STUDY COULD BE READ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149830 LOGIQ P9 ULTRASONIC IMAGING SYSTEM IYN GE ULTRASOUND KOREA, LTD. H42872LB LP9003946

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening