BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 3821136 · Received April 16, 2014

    Report

    Report Number
    9615050-2014-02742
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    January 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE TOUCHSCREEN DID NOT RESPOND WHEN PRESSED. DURING A REVIEW OF THE DEVICE HISTORY, MULTIPLE BUTTON ID: INVALID ALARM CODES WERE NOTED. THE PROBABLE CAUSE OF THE TOUCHSCREEN NOT RESPONDING WAS CORROSION ON THE TOUCHSCREEN 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

    DURING TESTING AT THE USER FACILITY, THE DEVICE TOUCHSCREEN DID NOT RESPOND. PRIOR TO TESTING, THE CUSTOMER CONTACT REPORTED THE DEVICE AUDIO SETTINGS WON'T TURN ON. NO ADD'L INFO WAS PROVIDED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233148 SYMBIQ SINGLE CHANNE 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA