BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS MEDICAL SYSTEM

    MDR report key: 8869999 · Received July 31, 2019

    Report

    Report Number
    8869999
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    July 23, 2019
    Report Date
    July 28, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LLZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ER CALLED AN AMI. PT WAS BROUGHT TO LAB AND LOADED ONTO TABLE. PT WAS CLEANED AND DRAPED PER PROTOCOL. ARTERIAL SHEATH WAS PLACED. WHEN TECH TRIED TO GUIDE C-ARM INTO PLACE TO OBTAIN IMAGES OF ARTERIES THE C-ARM DID NOT WORK. TECH RAN TO BACK AND REBOOTED MACHINE IN ATTEMPT TO CORRECT ERROR. MACHINE CAME BACK UP WITH SAME ERROR MESSAGE. PHYSICIAN DECIDED IT WAS BEST INTEREST OF PT TO CARE FLIGHT TO A HIGHER LEVEL OF CARE FACILITY TO FINISH HEART CATH. BIOMED AND APPROPRIATE PARTIES WERE NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638767 PHILIPS MEDICAL SYSTEM X-RAY, R&F ROOM, CARDIO LLZ PHILIPS MEDICAL SYSTEMS ALLURA XPER FD20

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention