BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 3963547 · Received May 30, 2014

    Report

    Report Number
    9615050-2014-03743
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    January 1, 2013
    Report Date
    December 17, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING THE DEVICE ALARMED WITH AN S321 (MOTOR ERROR-PMC, LEFT) MALFUNCTION ALARM CODE. ADDITIONAL TESTING OF THE DEVICE MECHANISM USING A TEST DEVICE FOUND THE DEVICE DID NOT ALARM WITH AN S321 MALFUNCTION ALARM CODE. THE PROBABLE CAUSE OF THE S321 MALFUNCTION ALARM CODE WAS A BROKEN ENCODER ON THE DEVICE MOTOR. THE CUSTOMER REPORTED S320 MALFUNCTION ALARM WAS NOT DUPLICATED; HOWEVER, WAS NOTED IN THE DEVICE HISTORY. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE MECHANISM WAS RETURNED TO THE SERVICE CTR WITH A REPORT FROM THE CUSTOMER OF AN S320 (LED ERROR-PMC, LEFT) MALFUNCTION ALARM CODE. NO ADDITIONAL INFO WAS PROVIDED. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SVC CTR, THE DEVICE ALARMED WITH THE S321 (MOTOR ERROR-PMC, LEFT) MALFUNCTION ALARM CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320076 SYMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA