BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCLAIM ENCORE 2.25

    MDR report key: 3853439 · Received April 4, 2014

    Report

    Report Number
    9615050-2014-02526
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 6, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K011096
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE AUDIBLE ALARMED A "RASPY" TONE WHEN THE DEVICE DOOR WAS OPENED. THIS WAS DUE TO THE PIEZO BUZZER. ADDITIONAL DURING TESTING, THE DEVICE DID NOT ALARM WHEN THE SLIDE CLAMP WAS NOT IN POSITION. THE WAS DUE TO THE SLIDE SENSOR FLAG WAS STUCK IN THE DOWN POSITION DUE TO SPILLAGE. THE PROBABLE CAUSE FOR SPILLAGE IS USE IN THE CUSTOMER ENVIRONMENT. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE DID NOT ALARM WHEN THE DEVICE DOOR WAS OPENED. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205085 ACCLAIM ENCORE 2.25 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA