BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYBIQ DCHANNEL 3.01

    MDR report key: 3842908 · Received March 13, 2014

    Report

    Report Number
    9615050-2014-01933
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    January 1, 2013
    Report Date
    July 22, 2013
    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
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING OF THE DEVICE MECHANISM THE DEVICE ALARMED WITH A S421 (MOTOR ERROR-PMC, RIGHT) MALFUNCTION ALARM CODE. THE PROBABLE CAUSE WAS A BROKEN MOTOR. THE CUSTOMER REPORTED S420 MALFUNCTION ALARM CODE WAS NOT DUPLICATED DURING TESTING. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTED 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 OF A S420 (LED-ERROR PMC RIGHT). NO ADD'L INFO WAS PROVIDED. THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER THE DEVICE ALARMED WITH S421 (MOTOR ERROR-PMC PUMP MECHANISM CONTROLLER, RIGHT) MALFUNCTION ALARM CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150202 SYBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA