BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 R

    MDR report key: 2051017 · Received April 4, 2011

    Report

    Report Number
    9615050-2011-00225
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 4, 2010
    Report Date
    March 8, 2011
    Manufacturer
    HOSPIRA COSTA RICA, LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT DURING TESTING AT THE USER FACILITY, THE DEVICE DISPLAYED E301 (AUDIO ALARM FAILURE) WITH NO AUDIBLE ALARM TONE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF 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
    1 PLMA DVC V11.51 1 R 80FRN FRN HOSPIRA COSTA RICA, LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA PLUM A+ SOFTWARE MODULE| LIST #20677, SN (B)(4)