BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SCHANNEL 3.01

    MDR report key: 2961707 · Received February 11, 2013

    Report

    Report Number
    9615050-2013-00217
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 16, 2013
    Manufacturer
    HOSPIRA HOLDINGS COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVAL. DURING TESTING AT THE USER FACILITY, THE DEVICE POWERED ON WITH A CASSETTE EJECT LEVER ALARM. THE CUSTOMER CONTACT REPORTED THE CHANNEL WAS RESET AND HAS BEEN RETURNED TO CLINICAL USE. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY IN THERAPY FOLLOWING AN ALARM CONDITION. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMED TO DELIVER AN UNSPECIFIED MEDICATION AND THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE REPORTED THE DEVICE ALARMED FOR A CASSETTE EJECT LEVER ALARM; HOWEVER, THE EMERGENCY EJECT LEVER HAD NOT BEEN PULLED. THE NURSE INDICATED THAT THE ALARM CONDITION COULD NOT BE CLEARED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. ALTHOUGH THERE WAS POTENTIAL FOR SERIOUS INJURY, THE CUSTOMER CONTACT INDICATED THERE WERE NO ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING TESTING AT THE USER FACILITY, THE DEVICE POWERED ON WITH A CASSETTE EJECT LEVER ALARM. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60224 SYMBIQ SCHANNEL 3.01 80FRN FRN HOSPIRA HOLDINGS COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK