BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TCM COMBIM

    MDR report key: 5140007 · Received October 9, 2015

    Report

    Report Number
    3002807968-2015-00023
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Date of Event
    January 1, 2015
    Report Date
    March 8, 2017
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    LKD
    PMA / PMN Number
    K093154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BY REPLACING THE MODULE WITH A NEWER MODULE (ABOVE RUN 0173) THE PROBLEM WAS SOLVED. THE ROOT CAUSE TO THIS PROBLEM WAS FOUND TO BE IDENTICAL TO THE ROOT CAUSE TO A PREVIOUS PROBLEM WHICH WAS CAUSING THE ERROR MESSAGE "SOUND HARDWARE CORRUPTED". THIS ISSUE WAS SOLVED FOR COMBIM MODULES FROM RUN 0174 AND ONWARDS AND IMPLEMENTED IN PRODUCTION IN (B)(6) 2014. ON VERY RARE OCCASIONS THIS PROBLEM MAY ALSO CAUSE THE TOO HIGH ALARM SIGNAL. A HEALTH RISK ASSESSMENT HAS BEEN PREPARED ON THIS ISSUE WITH THE FOLLOWING CONCLUSION: "IT IS CONSIDERED NOT LIKELY THAT THE DESCRIBED ERROR WILL LEAD TO ANY ADVERSE HEALTH CONSEQUENCES FOR THE EXPOSED PATIENTS BESIDES INCONVENIENCE OR TEMPORARY DISCOMFORT." RADIOMETER HAS INITIATED A CLASS III RECALL WITH RADIOMETER REF. FAN 915-343 IN ORDER TO INFORM ALL CUSTOMERS WITH A COMBIM MODULE BELOW RUN 0174 ABOUT THE PROBLEM. THE CUSTOMERS ARE INFORMED THAT IF THEY EXPERIENCE THAT THE ALARM SOUND IS HIGHER THAN THE PRE-SET VOLUME, THEY SHOULD IMMEDIATELY CONTACT THE LOCAL RADIOMETER SERVICE REPRESENTATIVE, WHOM WILL TAKE ACTION TO SOLVE THIS ISSUE PERMANENTLY.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 A SECOND REVISION OF THE RECALL WITH RADIOMETER REF. FAN (B)(4) WAS ISSUED. ALL THE POTENTIALLY AFFECTED TCM COMBIM MODULES AT CUSTOMER SITES WILL BE UPDATED. FDA IS CURRENTLY ASSESSING THE CLASSIFICATION OF THE RECALL. PLEASE REFER TO CRR 3002807968-03/08/16-001-C FOR FURTHER DETAILS.

    Additional Manufacturer Narrative · 1

    THE ANALYZER HAS BEEN TAKEN TO RADIOMETER'S WORKSHOP FOR FURTHER INVESTIGATION. UP TO NOW THE PROBLEM HAS NOT BEEN REPRODUCED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT AFTER RUNNING WITHOUT ANY PROBLEM AND WITH VOLUME CONTROL SET TO 1 THE ANALYZER GIVES AN ALARM WHICH IS SIGNIFICANTLY LOUDER THAN THE HIGHEST POSSIBLE ANALYZER VOLUME. ACCORDING TO THE INSTRUCTIONS FOR USE, THE ALARM SOUND PRESSURE AT THE HIGHEST ALARM SOUND LEVEL IS 83 DBA. AFTER SHUTTING DOWN AND RESTARTING THE ANALYZER THE PROBLEM DID NOT APPEAR AGAIN. ACCORDING TO OUR INFORMATION THE MONITOR WAS PLACED IN A NEONATAL WARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671000 TCM COMBIM TCM COMBIM MONITORING SYSTEM LKD RADIOMETER MEDICAL APS 903-111

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR