BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3978672 · Received June 4, 2014

    Report

    Report Number
    9615050-2014-03820
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 30, 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

    DURING TESTING THE DEVICE ALARMED WITH A S321 MALFUNCTION ALARM CORD. DURING A REVIEW OF THE DEVICE HISTORY THE S321 ALARMS WERE FOUND TO BE "QEP COUNT HIGH." THE PROBABLE CAUSE OF THE S321 MALFUNCTION ALARM CODE WAS DUE TO A BROKEN ENCODER ON THE MOTOR AND A BROKEN ADHESIVE SEAL DUE TO THE UNDER APPLICATION OF THE ADHESIVE SEAL OR THE ADHESIVE SEAL BEING APPLIED OVER GREASE. THE CUSTOMERS REPORTED S425 MALFUNCTION ALARM CODE WAS NOT DUPLICATED; HOWEVER, IT 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 WAS RETURNED TO THE SERVICE CENTER WITH A REPORT FROM THE CUSTOMER OF A MALFUNCTION OF S425. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS DOES NOT INDICATE A REPORTABLE EVENT. HOWEVER, DURING VERIFICATION TESTING 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
    325770 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA