BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 3964589 · Received May 30, 2014

    Report

    Report Number
    9615050-2014-03757
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 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
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING THE DEVICE ALARMED WITH A 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 A 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 (PLUNGER HOMING TIMEOUTS) WAS NOT DUPLICATED DURING TESTING; 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 OT THE SERVICE CENTER WITH A REPORT FROM THE CUSTOMER OF A S320 (PLUNGER HOMING TIMEOUTS) MALFUNCTION ALARM CODE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTIN AT THE SERVICE CENTER, THE DEVICE ALARMED WITH AN S321 (MOTOR ERROR-PMC, LEFT) MALFUNCTION ALARM CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318148 SYMBIQ DCHANNEL 3.01 80FRRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA