BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S3 UPS CHARGING MODULE

    MDR report key: 4912808 · Received July 8, 2015

    Report

    Report Number
    9611109-2015-00237
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 9, 2015
    Report Date
    February 22, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. SORIN GROUP DEUTSCHLAND MANUFACTURES THE S3 UPS CHARGING MODULE. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT WHEN DISCONNECTED FROM THE MAINS, THE SYSTEM WOULD NOT SWITCH TO INTERNAL POWER UNLESS THE EMERGENCY DISCHARGE IS ENABLED. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) MANUFACTURES THE S3 UPS CHARGING MODULE. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS ABLE TO CONFIRM THE REPORTED MALFUNCTION AND TRACED THE FAILURE TO A DEFECTIVE UPS CHARGE MODULE AND CONTROL MODULE. BOTH COMPONENTS WERE REPLACED TO RESOLVE THE ISSUE. SUBSEQUENT TESTING OF THE DEVICE FOUND NO FURTHER ISSUES. A REVIEW OF THE DHR DID NOT IDENTFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. LIVANOVA (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS TYPE OF ISSUE. EVALUATED ON SITE BY LIVANOVA TECHNICIAN.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT WHEN DISCONNECTED FROM THE MAINS, THE SYSTEM WOULD NOT SWITCH TO INTERNAL POWER UNLESS THE EMERGENCY DISCHARGE IS ENABLED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441837 S3 UPS CHARGING MODULE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND GMBH 28-92-80 NA

    Patients

    Seq Age Sex Outcome Treatment
    1