BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION HOSPITAL CART

    MDR report key: 15601296 · Received October 13, 2022

    Report

    Report Number
    3003761017-2022-00106
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    September 20, 2022
    Report Date
    June 26, 2024
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003138
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPANION HOSPITAL CART WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT COMPANION HOSPITAL CART S/N 50062 WAS SERVICED AND PASSED ALL FUNCTIONAL TESTING PRIOR TO BEING RELEASED TO FINISHED GOODS. VISUAL INSPECTION OF EXTERNAL COMPONENTS FOUND NO ABNORMALITIES. HOSPITAL CARD FAILED FUNCTIONAL TESTING FOR ACCEPTANCE AT INCOMING INSPECTION FOR SECTIONS ALL RELATED TO INABILITY TO INTERACT WITH THE LCD SCREEN, CONFIRMING REPORTED COMPLAINT. ADDITIONAL TESTING INCLUDED REPLACING THE LCD MODULE DUE TO INABILITY TO INTERACT WITH THE LCD SCREEN. HOSPITAL CART PASSED ALL AREAS OF FUNCTIONAL TESTING WITH REPLACEMENT MODULE, INCLUDING GROUND CONTINUITY TESTING. FAILURE INVESTIGATION FOR THIS COMPLAINT CONFIRMED HE REPORTED ISSUE AT INCOMING INSPECTION. THE CUSTOMER COMPLAINT WAS REPLICATED DURING TERSTING; THE ROOT CAUSE OF THE REPORTED INABILITY TO INTERACT WITH THE LCD SCREEN WAS DETERMINED TO BE A FAULTY LCD MODULE. FAILURE INVESTIGATION IDENTIFIED NO OTHER FAILURES OR DAMAGE THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE HOSPITAL CART WAS NOT SUPPORTING A PATIENT AT TIME OF COMPLAINT. THIS ISSUE WILL BE MONITORED AND TRENDED AS PART OF THE CUSTOMER COMPLAINT PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION AND IS CLOSING THIS FILE. IF NEW OR ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, SYNCARDIA WILL FILE A FOLLOW-UP MDR.

    Description of Event or Problem · 0

    THE COMPANION HOSPITAL CART WAS NOT SUPPORTING A PATIENT AT THE TIME OF THE EVENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE DISPLAY ON THE COMPANION HOSPITAL CART WAS "FROZEN", I.E., NOT RECOGNIZING TOUCH. THE HOSPITAL STAFF COULD NOT RECALIBRATE THE SCREEN.

    Description of Event or Problem · 0

    THE COMPANION HOSPITAL CART WAS NOT SUPPORTING A PATIENT AT THE TIME OF THE EVENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE DISPLAY ON THE COMPANION HOSPITAL CART WAS "FROZEN", I.E., NOT RECOGNIZING TOUCH. THE HOSPITAL STAFF COULD NOT RECALIBRATE THE SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2601360 SYNCARDIA COMPANION HOSPITAL CART HOSPITAL CART LOZ SYNCARDIA SYSTEMS, LLC 00858000003138

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown