BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+ PLATINUM MODU

    MDR report key: 3151460 · Received May 30, 2013

    Report

    Report Number
    9615050-2013-01436
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 24, 2013
    Manufacturer
    HSOPIRA COSTA RICA LTD
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    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

    DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE DEVICE DISPLAYED AN E301 (AUDIO ALARM FAILURE) ERROR CODE WITH NO AUDIBLE ALARM TONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237785 PLM A+ PLATINUM MODU 80FRN FRN HSOPIRA COSTA RICA LTD NA NA

    Patients

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