BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 3882724 · Received April 10, 2014

    Report

    Report Number
    9615050-2014-02593
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 11, 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
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION WAS DONE AT THE USER FACILITY BY THE FIELD SERVICE ENGINEER. DURING TESTING THE DEVICE TOUCHSCREEN WAS FOUND TO BE NONRESPONSIVE. THE PROBABLE CAUSE WAS DUE TO A BROKEN TOUCHSCREEN FRONT BEZEL ASSEMBLY. 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 CUSTOMER CONTACT REPORTED THE DEVICE TOUCHSCREEN WAS NON RESPONSIVE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A REPORT FORM THE NURSE THAT DURING PROGRAMMING THE DEVICE PRIOR TO PT USE THE TOUCHSCREEN WAS NONRESPONSIVE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN 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
    216344 SYMBIQ SINGLE CHANNE 80FRN FRN HOSPIRA COSTA RICA LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA