BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PM THERAPY S

    MDR report key: 3960363 · Received June 23, 2014

    Report

    Report Number
    9615050-2014-04135
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 19, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, THE DEVICE ALARMED WITH CHECK CASSETTE P ERROR CODE DURING THE DELIVERY ACCURACY TEST. THE PROBABLE CAUSE WAS DUE TO PROXIMAL PRESSURE SENSOR CALIBRATION DRIFT. THE 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 CTR WITH A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE AUDIBLY ALARMED WITH A CHECK CASSETTE ERROR CODE. THIS DID NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CTR IT WAS FOUND THE DEVICE PRESSURE SENSOR HAD DRIFTED OUT OF CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366123 GEMSTAR PM THERAPY S 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA