BEUDAMED
    FDA Adverse Event Death Summary report: N

    8010762-2012-00001

    MDR report key: 2434719 · Received January 25, 2012

    Report

    Report Number
    8010762-2012-00001
    Event Type
    Death
    Date Received
    January 25, 2012
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS INVESTIGATED BY A MAQUET FIELD SERVICE TECHNICIAN. THE DEVICE WAS TESTED ACCORDING TO THE SPECIFICATIONS. NO DEVICE PROBLEM FOUND. THE DEVICE MEETS THE SPECIFICATIONS. HEAD PERFUSIONIST CONFIRMS THAT THE UNIT DID NOT CAUSE THE PROBLEM. REFERENCE #: 705001238. UF/IMPORTER REPORT #: (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1