BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER V 13.

    MDR report key: 2844318 · Received November 8, 2012

    Report

    Report Number
    9615050-2012-01316
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    August 9, 2012
    Report Date
    August 15, 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

    TESTING AND INVESTIGATION FOUND THE DEVICE DISPLAYED E301 (AUDIO ALARM FAILURE) WITH NO AUDIBLE ALARM TONE. THIS WAS DUE TO THE PIEZO ALARM ASSEMBLY. 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 E301 (AUDIO ALARM FAILURE) WITH NO AUDIBLE ALARM TONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ DRIVER V 13. 80FRN FRN HOSPIRA COSTA RICA LTD NA NA

    Patients

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