BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 4113815 · Received September 17, 2014

    Report

    Report Number
    9615050-2014-05264
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 20, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MECHANISM WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. THE CUSTOMER CONTACT REPORTED THE BATTERY NEEDS RECONDITIONING AND DOOR WILL NOT RESET. THESE ARE NOT REPORTABLE MALFUNCTIONS. HOWEVER, DURING VERIFICATIONS TESTING AT THE SERVICE CTR OF THE DEVICE MECHANISM, AN S421 (MOTOR ERROR-PMC, RIGHT) MALFUNCTION ALARM CODE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575620 SYMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA