BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+ SPANISH DEVICE

    MDR report key: 3832820 · Received March 17, 2014

    Report

    Report Number
    9615050-2014-02018
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 19, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AT THE USER FACILITY. DURING TESTING, IT WAS NOTED THAT THE DEVICE DID NOT PASS THE CASSETTE TEST, 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, IT WAS NOTED THAT THE DEVICE DID NOT PASS THE CASSETTE TEST, THE FLUID SHIELD WAS DAMAGED, AND FLUID SPILLAGE WAS NOTED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. NO SPECIFIC PT INFORMATION, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156889 PLM A+ SPANISH DEVICE 80FRN FRN HOSPIRA COSTA RICA LTD NA NA

    Patients

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