BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION HOSPITAL CART

    MDR report key: 6112615 · Received November 18, 2016

    Report

    Report Number
    3003761017-2016-00375
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 14, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANION HOSPITAL CART S/N (B)(4) WAS NOT RETURNED TO SYNCARDIA FOR EVALUATION OF THIS COMPLAINT. INSTEAD, IT REMAINED AT THE SITE AND A SECOND COMPLAINT FOR THE SAME ISSUE WAS REPORTED ON JANUARY 27, 2017. (MFR. 3003761017-2017-00034) COMPANION HOSPITAL CART S/N (B)(4) WILL BE RETURNED TO SYNCARDIA FOR EVALUATION FOR THE SECOND COMPLAINT. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN MFR. 3003761017-2017-00034. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THE FILE. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PATIENT BECAUSE THE HOSPITAL CART WAS NOT IN USE WITH A PATIENT WHEN THE ISSUE WAS OBSERVED. IN ADDITION, IT WOULD NOT PREVENT A DOCKED COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION HOSPITAL CART WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4).

    Description of Event or Problem · 1

    THIS SYNCARDIA COMPANION HOSPITAL CART WAS NOT IN PATIENT USE. THE SYNCARDIA COMPANION HOSPITAL CART IS A LARGE CART WITH WHEELS INTO WHICH THE SYNCARDIA COMPANION 2 DRIVER DOCKS. IT IS INTENDED FOR USE IN THE HOSPITAL DURING THE TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) IMPLANT PROCEDURE AND SUBSEQUENT RECOVERY. THE TEAM MEMBER REPORTED THAT DURING CALIBRATION, THE TOUCH SCREEN ON COMPANION HOSPITAL CART S/N (B)(4) FAILED TO RESPOND TO THE OPERATOR'S TOUCH.

    Description of Event or Problem · 1

    THIS SYNCARDIA COMPANION HOSPITAL CART WAS NOT IN PATIENT USE. THE SYNCARDIA COMPANION HOSPITAL CART IS A LARGE CART WITH WHEELS INTO WHICH THE SYNCARDIA COMPANION 2 DRIVER DOCKS. IT IS INTENDED FOR USE IN THE HOSPITAL DURING THE TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) IMPLANT PROCEDURE AND SUBSEQUENT RECOVERY. THE TEAM MEMBER REPORTED THAT DURING CALIBRATION, THE TOUCH SCREEN ON COMPANION HOSPITAL CART S/N (B)(4) FAILED TO RESPOND TO THE OPERATOR'S TOUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764366 SYNCARDIA COMPANION HOSPITAL CART HOSPITAL CART LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1