BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 SP NEW

    MDR report key: 3896008 · Received May 15, 2014

    Report

    Report Number
    9615050-2014-03443
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 17, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE PROXIMAL OCCLUSION TEST AT THE SERVICE CENTER THE DEVICE ALARMED CHECK CASSETTE P. FURTHER TESTING FOUND THE DEVICE PROXIMAL PRESSURE SENSOR HAD DRIFTED OUT OF CALIBRATION. THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL 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 FROM THE CUSTOMER CONTACT THAT DURING PREVENTATIVE MAINTENANCE TESTING THE DEVICE DID NOT PASS THE PROXIMAL OCCLUSION TEST AND ALARMED WITH A CHECK CASSETTE ERROR CODE; HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER THE DEVICE PROXIMAL PRESSURE SENSOR WAS FOUND TO HAVE DRIFTED OUT OF CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290550 GEMSTAR 7 SP NEW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA