BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 SP NEW

    MDR report key: 3874241 · Received April 18, 2014

    Report

    Report Number
    9615050-2014-02820
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Report Date
    February 25, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    FA302-2
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING AND INVESTIGATION AT THE SERVICE CENTER, THE DEVICE ALARMED WITH A CHECK CASSETTE D ALARM. THE PROBABLE CAUSE WAS DUE TO THE DISTAL PRESSURE SENSOR OF THE DEVICE WAS FOUND TO HAVE 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 CUSTOMER CONTACT REPORTED DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH A CHECK CASSETTE ALARM. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER THE DISTAL PRESSURE SENSOR OF THE DEVICE WAS FOUND TO HAVE DRIFTED OUT OF CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238533 GEMSTAR 7 SP NEW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA