BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    80FRN

    MDR report key: 3802043 · Received February 4, 2014

    Report

    Report Number
    9615050-2014-00857
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 10, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    FA212-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AT THE USER FACILITY. DURING TESTING, THE SENSOR ON THE FLUID SHIELD WAS FOUND TO BE DAMAGED AND FLUID SPILLAGE WAS NOTED. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING TESTING AT THE USER FACILITY, THE SENSOR ON THE FLUID SHIELD WAS FOUND TO BE DAMAGED AND FLUID SPILLAGE WAS NOTED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A NOTE THAT INDICATED MALFUNCTION N251 (CASSETTE TEST TAILED). NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73764 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE, LIST #UNK, SN UNK