BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 3895997 · Received May 15, 2014

    Report

    Report Number
    9615050-2014-03448
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 18, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE DID NOT ALARM WHEN AN OCCLUSION WAS PRESENT PROXIMAL TO THE DEVICE. THE PROBABLE CAUSE WAS DUE TO CONTAMINATION ON THE PROXIMAL SENSOR PIN. THE CONTAMINATION PREVENTED PROPER MOVEMENT OF THE PIN; THEREFORE, THE DEVICE DID NOT DETECT CHANGES IN PRESSURE. THE CONTAMINATION IS A RESULT OF USE IN THE CUSTOMER ENVIRONMENT. 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 THAT DURING PREVENTATIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE DID NOT ALARM WHEN A PROXIMAL OCCLUSION WAS PRESENT. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290821 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA