BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 SP REFURB

    MDR report key: 3853988 · Received April 17, 2014

    Report

    Report Number
    9615050-2014-02758
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    FA202-02
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING AT THE SERVICE CENTER IT WAS FOUND THE PROXIMAL PRESSURE SENSOR HAD DRIFTED OTU OF CALIBRATION. THE CUSTOMER REPORTED CHECK CASSETTE ALARM WAS DUPLICATED DURING TESTING. THE REPORTED KEYPAD ALARM WAS NOT DUPLICATED; HOWEVER, WAS NOTED IN THE DEVICE HISTORY. 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 WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF DURING PREVENTIVE MAINTENANCE TESTING THE DEVICE ALARMED WITH A CHECK CASSETTE AND KEYPAD ALARM CODE. THERE WAS NO INDICATION OF A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE PRESSURE SENSOR HAD DRIFTED OUT OF CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236002 GEMSTAR 7 SP REFURB 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA