BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PM THERAPY S

    MDR report key: 3832504 · Received March 27, 2014

    Report

    Report Number
    9615050-2014-02342
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 22, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    FA302-02
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING AT THE SERVICE CENTER, THE DEVICE ALARMED WITH A CHECK CASSETTE P ERROR CODE. THIS WAS FOUND TO BE DUE TO THE PROXIMAL POT HAD DRIFTED OUT OF CALIBRATION. THIS 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

    THE DEVICE RETURNED TO THE SERVICE CENTER WITH A REPORT FROM THE CUSTOMER CONTACT DURING PREVENTATIVE MAINTENANCE TESTING, THE DEVICE DISPLAYED A CHECK CARTRIDGE ERROR CODE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE DEVICE ALARMED WITH A CHECK CASSETTE-P ALARM CODE AND THE PROXIMAL PRESSURE SENSOR DRIFT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179556 GEMSTAR PM THERAPY S 80FRN FRN HOSPIRA COSTA RICA LTD. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA