BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER ED 2

    MDR report key: 3113121 · Received May 9, 2013

    Report

    Report Number
    9615050-2013-01115
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 11, 2013
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE DOOR ROLLER WAS MISSING AND THE DOOR ROLLER PIN AS BROKEN. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DOOR ROLLER WAS BROKEN. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR A REPORT OF A BROKEN DOOR LEVER AND DOOR ROLLER. NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFO, 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. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202620 PLUM A+ DRIVER ED 2 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LIST #20791, SN (B)(4)| PLUM A+ SOFTWARE MODULE: