BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 3.13 DUAL CHA

    MDR report key: 3823296 · Received March 20, 2014

    Report

    Report Number
    9615050-2014-02170
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 31, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    Z-0070-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE LOWER LEFT AND TOP BUTTONS OF THE DEVICE TOUCHSCREEN DID NOT RESPOND. THE PROBABLE CAUSE WAS DUE TO CONTAMINATION ON THE LOWER LEFT AND TOP CORNER OF THE TOUCHSCREEN DUE TO FLUID INGRESS. THE CUSTOMER REPORTED S104 (PRIMARY AUDIBLE ALARM FAILURE) MALFUNCTION ALARM CODE WAS DUPLICATED DURING TESTING. THIS 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 CENTER WITH A REPORT FROM THE CUSTOMER CONTACT OF A S104 (PRIMARY AUDIBLE ALARM FAILURE) MALFUNCTION ALARM CODE. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE DEVICE TOUCHSCREEN LEFT LOWER CORNER BUTTONS DO NOT RESPOND WHEN PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167369 SYMBIQ 3.13 DUAL CHA 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA