BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCLAIM ENCORE 2.25

    MDR report key: 2142207 · Received May 26, 2011

    Report

    Report Number
    9615050-2011-00378
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 THE GROUND PRONG ON THE AC POWER CORD PLUG WAS MISSING. THE PUMP WAS RETURNED TO THE BIOMEDICAL TECHNICIAN FOR AN UNSPECIFIED REASON. NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE GROUND PRONG ON THE AC POWER CORD PLUG WAS MISSING. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE PUMP WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK