BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 N

    MDR report key: 3964053 · Received May 5, 2014

    Report

    Report Number
    9615050-2014-03201
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 27, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    Z-0624-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, IT WAS NOTED THAT THE DEVICE DOOR ROLLER WAS BROKEN OFF. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THE CUSTOMER CONTACT'S REPORTED E302 (BACKLIGHT FAILURE) WAS DUPLICATED DURING TESTING. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE WAS REC'D IN THE BIOMEDICAL DEPARTMENT WITH AN UNSIGNED NOTE STATING, "BROKEN" AND THAT E302 (BLACKLIGHT FAILURE) WAS NOTED. THESE ARE NOT REPORTABLE MALFUNCTIONS. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, IT WAS NOTED THAT THE DEVICE DOOR ROLLER WAS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267906 PLMA DVC V11.51 1 N 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA PLUM A+ SOFTWARE MODULE, LIST 12097, (B)(4)