BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XL PLS MIC/MAC

    MDR report key: 4210837 · Received August 1, 2014

    Report

    Report Number
    9615050-2014-04657
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 15, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K952799
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 THE DEVICE AC POWER CORD GROUND PRONG WAS BROKEN/MISSING. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. NO SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE PROVIDED. THERE WERE NO REPORTS OF ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPY WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451943 PLUM XL PLS MIC/MAC 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK