BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACQSIM CT SCANNER

    MDR report key: 4024938 · Received August 12, 2014

    Report

    Report Number
    MW5037775
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 11, 2014
    Manufacturer
    PHILIPS
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PHILIPS IS NOT PROVIDING INSTRUCTIONS PURSUANT TO 21CFR 1020.30-33, 1040.10-11 AND 820.170 (21CFR) FOR THE ACQSIM CT SCANNER K03357 CLEARED 01/09/2004. THE PREDICATE DEVICE FOR THE ACQSIM IS THE 1200SX WHICH DOES NOT APPEAR TO HAVE 510K CLEARANCE. PHILIPS ALSO REQUIRES AN APPLICATION TO BE EXECUTED BEFORE ALLOWING ACCESS TO INSTRUCTION PURSUANT TO 21CFR. THIS APPLICATION LAWS ARE BASED ON THE (B)(4) LAWS AS THE GUIDING PRINCIPAL. ACQSIM CT SCANNER LOCATED IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479702 ACQSIM CT SCANNER CT SCAN JAK PHILIPS ACQSIM

    Patients

    Seq Age Sex Outcome Treatment
    1