BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 3964586 · Received May 30, 2014

    Report

    Report Number
    9615050-2014-03765
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    January 1, 2011
    Report Date
    March 21, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042800
    Removal / Correction Number
    FA305-02
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING. NO E630 (SCREW ROTATION ERROR) ERROR CODE OCCURRED DURING TESTING; HOWEVER AN E630 (SCREW ROTATION ERROR) ERROR CODE WAS NOTED IN THE DEVICE HISTORY BUT WAS NOT DUPLICATED DURING TESTING. ALTHOUGH THE DEVICE PASSED TESTING, THE DEVICE HAS BEEN IDENTIFIED A PART OF A PRODUCT RECALL. 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 CENTER WITH A REPORT FROM THE CUSTOMER OF A S320 (PLUNGER HOMING TIMEOUTS) MALFUNCTION ALARM COE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE DEVICE ALARMED WITH AN S31 (MOTOR ERROR-PMC, LEFT) MALFUNCTION ALARM CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318149 SYMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA