BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 SENSOR MODULE FOR BUBBLE DETECTOR

    MDR report key: 6046855 · Received October 21, 2016

    Report

    Report Number
    9611109-2016-00701
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    September 27, 2016
    Report Date
    September 27, 2016
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTW
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) NUMBER PROVIDED IN THE INITIAL REPORT, SUBMITTED OCTOBER 21, 2016, WAS INCORRECT. THE CORRECT 510(K) NUMBER IS K071318.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE SORIN S5 SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE S5 SENSOR MODULE FOR BUBBLE DETECTOR CAUSED AN ERROR APPEAR ON THE S5 DISPLAY MODULE DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT. THE SERVICE REPRESENTATIVE REPLACED THE BUBBLE SENSOR MODULE TO RESOLVE THE ISSUE. THE REPLACED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR FURTHER INVESTIGATION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE S5 SENSOR MODULE FOR BUBBLE DETECTOR CAUSED AN ERROR APPEAR ON THE S5 DISPLAY MODULE DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698423 S5 SENSOR MODULE FOR BUBBLE DETECTOR CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTW SORIN GROUP DEUTSCHLAND 23-45-20

    Patients

    Seq Age Sex Outcome Treatment
    1