BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA NEW 802.11 AB

    MDR report key: 2102900 · Received May 4, 2011

    Report

    Report Number
    9615050-2011-00323
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 6, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 DEVICE DID NOT DELIVER A DOSE WHEN THE PATIENT PENDANT WAS PRESSED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED, "BROKEN." NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THE CUSTOMER CONTACT REPORTED THE DEVICE WAS RECEIVED WITHOUT A PATIENT PENDANT. DURING TESTING AT THE USER FACILITY USING A TEST PENDANT, THE DEVICE DID NOT DELIVER A DOSE WHEN THE PATIENT PENDANT WAS PRESSED. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LC PCA NEW 802.11 AB 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK