BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAGNOST 97-MCP/SCP-DSI

    MDR report key: 2060873 · Received March 11, 2011

    Report

    Report Number
    3003768277-2011-00282
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Report Date
    February 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    JAA
    PMA / PMN Number
    K912470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THEY REGULARLY DO NOT HAVE ANY FLUOROSCOPY AND THEN THEY CANNOT MAKE RECORDINGS. AFTER RESTARTING THE SYSTEM, EVERYTHING THEN WORKS AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAGNOST 97-MCP/SCP-DSI JAA PHILIPS HEALTHCARE 70853

    Patients

    Seq Age Sex Outcome Treatment
    1