BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+ PLATINUM MODU

    MDR report key: 1880976 · Received October 5, 2010

    Report

    Report Number
    2921482-2010-00760
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 7, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL TESTING OF THE DEVICE WAS CONDUCTED AT THE USER FACILITY BY THE HOSPIRA FIELD SERVICE ENGINEER ON (B)(6) 2010. THE AC POWER CORD IS EXPECTED TO BE RETURNED FOR FURTHER TESTING. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE GROUND PRONG ON THE AC POWER CORD PLUG WAS BENT. THE PUMP WAS RETURNED TO THE STERILE PROCESSING DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED, ¿BROKEN.¿ NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE GROUND PRONG ON THE AC POWER CORD WAS BENT. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE PUMP WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM A+ PLATINUM MODU 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LIST #12680, SN UNKNOWN| PLUM A+ SOFTWARE MODULE