BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR PM PMP ENGLISH

    MDR report key: 3243146 · Received July 18, 2013

    Report

    Report Number
    9615050-2013-02097
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 20, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT BEEN REC'D. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE WAS FOUND AT A SETTING DIFFERENT THAN ORIGINALLY PROGRAMMED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A REPORT THAT PRIOR TO PT USE, THE DEVICE "AUTOMATICALLY GOES INTO CONTINUOUS/DOES NOT RECORD AMOUNT GIVE." NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335384 GEMSTR PM PMP ENGLISH 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA