BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ UK WITH 3PIN

    MDR report key: 3842886 · Received March 10, 2014

    Report

    Report Number
    9615050-2014-01824
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 11, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    FA212-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE DID NOT ALARM WHEN A DISTAL OCCLUSION WAS PRESENT. THIS WAS DUE TO A BROKEN DISTAL PRESSURE SENSOR PIN. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE DISTAL PRESSURE SENSOR PIN WAS BROKEN. THERE WERE NO REPORTS OF ADVERSE PT EVENTS OR DELAYS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142005 PLUM A+ UK WITH 3PIN 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

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