BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER NEW 8

    MDR report key: 2802440 · Received October 18, 2012

    Report

    Report Number
    9615050-2012-01248
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 18, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    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 INFO 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 E301 (AUDIO ALARM FAILURE) WITH NO AUDIBLE ALARM TONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ DRIVER NEW 8 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

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