BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 4143041 · Received September 12, 2014

    Report

    Report Number
    9615050-2014-05219
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 29, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY, DURING TESTING, THE DEVICE DID NOT ALARM WITH A S233 (OVERTEMPERATURE-PSC) MALFUNCTION ALARM CODE; HOWEVER, MULTIPLE S233 MALFUNCTION ALARM CODES WERE NOTED IN THE DEVICE HISTORY. FURTHER TESTING FOUND THAT THE DEVICE FAN DID NOT FUNCTION. THE PROBABLE CAUSE OF THE S233 MALFUNCTION ALARM WAS A BROKEN DEVICE COOLING 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 THAT THE DEVICE ALARMED WITH A S233 (OVER TEMPERATURE-PSC) MALFUNCTION ALARM CODE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED "ALARMS MALFUNCTION S233". NO INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, A S233 MALFUNCTION ALARM CODE WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565255 SYMBIQ SINGLE CHANNE 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK