BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC CATH

    MDR report key: 9516224 · Received December 23, 2019

    Report

    Report Number
    MW5091863
    Event Type
    Injury
    Date Received
    December 23, 2019
    Date of Event
    November 3, 2019
    Report Date
    December 20, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V./ PHILIPS
    Product Code
    IZI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HARD DRIVE ON CARDIAC CATH CRASHED RESULTING IN IMAGES OBTAINED DURING STUDY TO BE DELETED AND UNABLE TO BE RECOVERED. SITE # (B)(4); SOFTWARE RELEASE # 8.1.17.2. FDA SAFETY REPORT ID # (B)(4)(

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308709 CARDIAC CATH SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V./ PHILIPS ALLURA FD20

    Patients

    Seq Age Sex Outcome Treatment
    1