BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1320894-2008-00127

    MDR report key: 1250657 · Received August 29, 2008

    Report

    Report Number
    1320894-2008-00127
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Product Code
    MLN
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IS RETAINED AT THE HOSP. A TEAM OF ENGINEERS WERE ALLOWED TO EXAMINE AND TEST THE ACTUAL DEVICE AT THE USER FACILITY. THE ENGINEERS REPORT HAS BEEN COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED AT THAT TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1