BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+ PLANTINUM

    MDR report key: 4210848 · Received August 1, 2014

    Report

    Report Number
    9615050-2014-04665
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 4, 2014
    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
    CA
    Reporter Occupation
    OTHER

    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

    THE CUSTOMER CONTACT REPORTED THAT DURING IMPLEMENTATION OF WAVE 2 REMEDIATION OF THE PLUM DEVICE, IT WAS NOTED THE DEVICE DID NOT AUDIBLY ALARM AT AN UNSPECIFIED POINT WHEN THE VOLUME KNOB WAS TURNED TO THE LOW VOLUME POSITION. IT WAS REPORTED A FEW E301 (AUDIO ALARM FAILURE) ERROR CODES WERE NOTED IN THE DEVICE HISTORY. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452143 PLM A+ PLANTINUM 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

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