BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1163328 · Received September 18, 2008

    Report

    Report Number
    9616240-2008-00051
    Event Type
    Other
    Date Received
    September 18, 2008
    Manufacturer
    GAMBRO DASCO S.P.A., MONITOR DIVISION
    Product Code
    FII
    PMA / PMN Number
    k070643
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE MACHINE WAS INSPECTED BY A GAMBRO SVC TECH ON (B)(4) 2008. HE FOUND THE MACHINE TO BE PROPERLY CALIBRATED, FUNCTIONING CORRECTLY, AND WITHIN MFR'S SPECS. THE MACHINE HAS BEEN RETURNED TO SVC, WITH NO PROBLEMS REPORTED. NEITHER THE PHYSICIAN, NOR THE CLINICAL STAFF BELIEVES THAT A DEVICE MALFUNCTION OCCURRED, NOR DO THEY BELIEVE THAT A GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THE PT'S DEATH. THIS EVENT IS BEING REPORTED PER GAMBRO POLICY: ALL CASES OF PT DEATH OCCURRED DURING TREATMENT OR WITHIN 24 HRS AFTER END OF THE TREATMENT ARE CONSIDERED REPORTABLE REGARDLESS OF ANY INVOLVEMENT OF A GAMBRO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * FII GAMBRO DASCO S.P.A., MONITOR DIVISION * *

    Patients

    Seq Age Sex Outcome Treatment
    1