BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 3823379 · Received March 20, 2014

    Report

    Report Number
    9615050-2014-02201
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 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

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING AT THE USER FACILITY, MULTIPLE S233 (OVERTEMPERATURE-PSC) MALFUNCTION ALARM CODES WERE NOTED IN THE DEVICE HISTORY AND THE FAN DID NOT SOUND LIKE IT WAS RUNNING SMOOTHLY. THE PROBABLE CAUSE WAS DUE TO A BROKEN FAN. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA.

    Description of Event or Problem · 1

    DURING TESTING AT THE USER FACILITY, MULTIPLE S233 (OVERTEMPERATURE-PSC) MALFUNCTION ALARM CODES WERE NOTED IN THE DEVICE HISTORY AND THE FAN DID NOT SOUND LIKE IT WAS RUNNING SMOOTHLY. PRIOR TO TESTING, THE DEVICE HAD BEEN RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167905 SYMBIQ SINGLE CHANNE 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK