BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 1.6 W/DATAPORT

    MDR report key: 3023103 · Received February 26, 2013

    Report

    Report Number
    9615050-2013-00279
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 29, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K911401
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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 CHARRING WAS NOTED ON THE STRAIN RELIEF OF THE FEMALE END OF THE AC POWER CORD. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT WITH AN UNSIGNED NOTE THAT STATED "DAMAGED." NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, CHARRING WAS NOTED ON THE STRAIN RELIEF ON THE FEMALE END OF THE AC POWER CORD. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN 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
    83162 PLUM 1.6 W/DATAPORT 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK