BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SCHANNEL 3.01

    MDR report key: 4102391 · Received August 27, 2014

    Report

    Report Number
    9615050-2014-04997
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 11, 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

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING, OVERTEMPERATURE MALFUNCTION ALARM CODES WERE NOTED IN THE DEVICE HISTORY LOG AND THE FAN WAS NOT SPINNING PROPERLY. THE PROBABLE CAUSE OF THE CUSTOMER REPORTED EVENT WAS DUE TO A BROKEN FAN. 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 THE DEVICE HAD OVERTEMPERATURE MALFUNCTION ALARM CODES. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR A SECOND TIME, FROM AN UNSPECIFIED FLOOR FOR THE OVERTEMPERATURE ALARM CODES. NO PUMP PROGRAMMING, OR EVENT DETAILS WERE PROVIDED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, OVERTEMPERATURE MALFUNCTION ALARM CODES WERE NOTED IN THE DEVICE HISTORY LOG AND THE FAN WAS NOT SPINNING PROPERLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518927 SYMBIQ SCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA