BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNEL

    MDR report key: 2974195 · Received February 19, 2013

    Report

    Report Number
    9615050-2013-00257
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 22, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND AT POWER UP, THE DEVICE DISPLAYED A WHITESCREEN ERROR AND THE DEVICE SOUNDED AN AUDIBLE ALARM FROM THE SECONDARY BEEPER. THIS WAS DUE TO THE HARDWARE MODULE. AS INDICATED, THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A WHITESCREEN ERROR. DURING TESTING AT THE USER FACILITY AFTER THE DEVICE WAS POWER ON, THE DEVICE ALARMED WITH A WHITESCREEN ERROR. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72424 SYMBIQ SINGLE CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA