BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 3821126 · Received April 16, 2014

    Report

    Report Number
    9615050-2014-02730
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 17, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    Z-0069-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION AT THE SERVICE CENTER FOUND THE DEVICE TOUCHSCREEN DID NOT RESPOND WHEN PRESSED. THE PROBABLE CAUSE WAS CORROSION ON THE BOTTOM EDGE OF THE TOUCHSCREEN AND FRONT "BEZED" DUE TO FLUID INGRESS. THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED DURING PROGRAMMING PRIOR TO PT USE THE DEVICE TOUCHSCREEN DID NOT RESPOND WHEN PRESSED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THE CUSTOMER CONTACT REPORTED DURING TESTING AT THE USER FACILITY THE TOUCHSCREEN DID NOT RESPOND AND NO FURTHER TESTING COULD BE COMPLETED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232533 SYMBIQ SINGLE CHANNE 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA