BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILLIPS MX 8000 IDT

    MDR report key: 1937912 · Received December 20, 2010

    Report

    Report Number
    MW5018665
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    October 6, 2010
    Report Date
    December 20, 2010
    Manufacturer
    PHILIPS MEDICAL
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FAILURE TO PROVIDE ADEQUATE AIAT INFO, INCLUDING AIAT PASSWORD FOR TESTING OF XRAY AND DETECTION SYSTEM, EXPOSED PT TO UNNECESSARY RADIATION PER (B)(6). FAILURE TO PROVIDE INSTRUCTIONS PER (B)(6). DATES OF USE: (B)(6) 2010 - (B)(6) 2010, 60 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILLIPS MX 8000 IDT MX 8000 IDT JAK PHILIPS MEDICAL MX 8000 IDT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other