BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 1173783 · Received September 8, 2008

    Report

    Report Number
    9616026-2008-00010
    Event Type
    Death
    Date Received
    September 8, 2008
    Manufacturer
    GAMBRO LUNDIA AB, MONITOR DIV.
    Product Code
    MQS
    PMA / PMN Number
    k072093
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICAL DATA FILES WITH INFO ABOUT THE TREATMENT ARE NOT AVAILABLE ACCORDING TO THE HOSP'S BIOMEDICAL TECHS. THE PRISMAFLEX MACHINE WAS INSPECTED BY THE HOSP'S BIOMED TECHS AND IT WAS FOUND TO BE OPERATING WITHIN THE MFR'S SPECS. IT WAS AUTHORIZED TO BE RETURNED TO CLINICAL USE ON JULY 11. THIS EVENT IS BEING REPORTED AS PER GAMBRO POLICY: ALL CASES OF PT'S DEATH WITHIN 24 HRS OF TREATMENT ARE CONSIDERED REPORTABLE REGARDLESS OF ANY INVOLVEMENT OF A GAMBRO DEVICE. GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT ITS DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * MQS GAMBRO LUNDIA AB, MONITOR DIV. * *

    Patients

    Seq Age Sex Outcome Treatment
    1