BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCLAIM ENCORE

    MDR report key: 1052975 · Received May 27, 2008

    Report

    Report Number
    2921482-2008-00169
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 5, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K991501
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT THE DEVICE DID NOT ALARM WHEN A DISTAL OCCLUSION WAS PRESENT. THIS WAS DUE TO CONTAMINATION ON THE DISTAL PRESSURE SENSOR. A CALIBRATED SET WAS USED FOR TESTING PER THE DEVICE RELEASE SPECIFICATIONS. THE EVENT THAT IS BEING REPORTED WAS NOTED DURING VERIFICATION TESTING; THEREFORE, USER FACILITY EVENT CODES ARE NOT APPLICABLE IN THIS CASE.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE MANUFACTURING FACILITY, THE DEVICE DID NOT ALARM WHEN A DISTAL OCCLUSION WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCLAIM ENCORE 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA