BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 727561 · Received June 1, 2006

    Report

    Report Number
    9616240-2006-00329
    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 REPORTED. THE AMOUNT OF BLOOD LOSS IS UNK BUT NO MEDICAL INTERVENTION WAS REQUIRED. CLINICAL INVESTIGATION IS ONGOING. DURING CALLING FOR TROUBLESHOOTING WITH INTENSIVE CARE THERAPY SPECIALIST, CUSTOMER NOTED THAT THE DIALYSATE SCALE WAS OUT OF CALIBRATION. SCALES WERE CALIBRATED AND THEN THE MACHINE OPERATED PROPERLY. 510(K)# IS K010805

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1