BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNEL

    MDR report key: 3894452 · Received April 25, 2014

    Report

    Report Number
    9615050-2014-02999
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    February 24, 2014
    Report Date
    March 13, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPITAL PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SVC CTR WITH A REPORT FROM THE CUSTOMER CONTACT THAT THE FRONT BEZEL AND BATTERY NEED TO BE REPLACED. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING TESTING AT THE SVC CTR, THE DEVICE TOUCHSCREEN WAS FOUND NOT TO RESPOND WHEN PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252647 SYMBIQ SINGLE CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA