BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ UK WITH 3PIN

    MDR report key: 3982677 · Received July 24, 2014

    Report

    Report Number
    9615050-2014-04555
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT THE DEVICE CAPACITOR ON THE CPU (CENTRAL PROCESSING UNIT) PRINTED CIRCUIT BOARD WAS BURNED. THE PROBABLE CAUSE FOR THE CUSTOMER CONTACT'S REPORTED BURN SMELL WAS DUE TO A DAMAGED CPU CIRCUIT BOARD. 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 A BURNING SMELL FROM THE DEVICE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A REPORT OF BURNING SMELL. NO SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT PROVIDED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CLINICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE ENGINEERING MANAGER WAS UNABLE TO CONFIRM THE BURNING SMELL. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434985 PLUM A+ UK WITH 3PIN 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

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