BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER ED 2

    MDR report key: 3955441 · Received June 12, 2014

    Report

    Report Number
    9615050-2014-03982
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 20, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    Z0624-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING, IT WAS NOTED THAT THE DEVICE DOOR ROLLER AND DOOR ROLLER PIN WERE BROKEN. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. 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 DOOR ROLLER AND DOOR ROLLER PIN WERE BROKEN. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR A REPORT OF BROKEN DOOR ROLLER AND BROKEN DOOR PIN. NO INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE DOOR ROLLER AND DOOR ROLLER PIN WERE BROKEN. NO ADDITIONAL INFORMATION WAS PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346600 PLUM A+ DRIVER ED 2 80FRN FRN HOSPIRA COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 PLUM A+ SOFTWARE MODULE, LIST #20791, SN UNK