BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9616240-2006-00330

    MDR report key: 727571 · Received June 1, 2006

    Report

    Report Number
    9616240-2006-00330
    Event Type
    Malfunction
    Date Received
    June 1, 2006
    Product Code
    FII
    PMA / PMN Number
    k010805
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INJURY WAS REPORTED. CLINICAL INVESTIGATION IS ONGOING. DURING A FOLLOW-UP DISCUSSION, IT WAS LEARNED THAT THE MACHINE HAD BEEN PULLED FROM SERVICE. 510(K)# IS K010805

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FII

    Patients

    Seq Age Sex Outcome Treatment
    1