BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 2974588 · Received January 29, 2013

    Report

    Report Number
    3003761017-2013-00015
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 29, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FAILURE MODE POSES A LOW RISK TO A PATIENT, BECAUSE THE ISSUE WAS OBSERVED DURING A ROUTING CONSOLE CHECKOUT AND THE CSS CONSOLE WAS NOT SUPPORTING A PATIENT. IN ADDITION, IT DOSE NOT NEGATE THE ABILITY OF THE CSS CONSOLE TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THE COMPUTER IS A MONITORING DEVICE ONLY AND DOES NOT CONTROL CSS CONSOLE FUNCTIONALITY. IN THE EVENT OF A MONITORING COMPUTER FAILURE, USER TRAINING DIRECTS THE PATIENT CARE STAFF TO UTILIZE STANDARD, AND READILY AVAILABLE, PATIENT MONITORING EQUIPMENT, SUCH AS PULSE OXIMETERS FOR MONITORING PO2 LEVEL, SPHYGMOMANOMETER FOR MONITORING BLOOD PRESSURE, AND THE MONITORING OF BREATH SOUND FOR INDICATIONS OF PULMONARY EDEMA. SYNCARDIA HAS COMPLETED IT'S EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    THIS CSS CONSOLE WAS NOT SUPPORTING A PATIENT. THE CUSTOMER REPORTED THAT DURING A ROUTINE CONSOLE CHECKOUT, THE MONITORING COMPUTER DID NOT BOOT UP. A REPLACEMENT MONITORING COMPUTER DID NOT BOOT UP. A REPLACEMENT MONITORING COMPUTER WAS SENT TO THE CUSTOMER AND WAS INSTALLED ON THE CSS CONSOLE. AFTER INSTALLATION, THE CSS CONSOLE PASSED THE CONSOLE TEST VALIDATION PROTOCOL. THE MONITORING COMPUTER THAT WAS REMOVED FROM THE CSS CONSOLE WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FAULTY HARD DRIVE. THE HARD DRIVE WAS REPLACED, AND THE COMPUTER PERFORMED AS INTENDED. NO EVALUATION OF THE CSS CONSOLE COMPUTER HARD DRIVE WILL BE CONDUCTED, BECAUSE THE HARD DRIVE EXHIBITED THE SAME FAILURE MODE AS PREVIOUSLY-INVESTIGATED COMPUTER HARD DRIVE. PREVIOUS INVESTIGATION DETERMINED THAT THE PHYSICAL CONDITION OF THE MEDIA IN THE HARD DISK DRIVE DEGRADED. AN ELECTRONIC FAILURE OF THE HARD DISK DRIVE DAMAGED THE READ/WRITE HEAD(S), ULTIMATELY LEADING TO LAPTOP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39790 SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE CIRCULATORY ASSIST DRIVE LOZ SYNCARDIA SYSTEMS, INC. CSS CONSOLE 4

    Patients

    Seq Age Sex Outcome Treatment
    1