BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIDECO ELECTA

    MDR report key: 2974822 · Received February 12, 2013

    Report

    Report Number
    1718850-2013-00008
    Event Type
    Other
    Date Received
    February 12, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 17, 2013
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    CAC
    PMA / PMN Number
    K020647
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE ELECTA BOWL. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE THE ELECTA BOWL WAS NOISY. THERE WERE NO OTHER ISSUES AND THE CLINICIAN ELECTED TO COMPLETE THE PROCEDURE WITH THE BOWL. THERE WAS NO PATIENT INJURY. THIS ISSUE WAS REPORTED TO THE COUNTRY'S COMPETENT AUTHORITY. THIS MEDWATCH IS BEING FILED AS A RESULT OF THIS ACTION. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE THE ELECTA BOWL WAS NOISY. THERE WERE NO OTHER ISSUES AND THE CLINICIAN ELECTED TO COMPLETE THE PROCEDURE WITH THE BOWL. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62132 DIDECO ELECTA APPARATUS, AUTOTRANSFUSION CAC SORIN GROUP ITALIA NA 1209110091

    Patients

    Seq Age Sex Outcome Treatment
    1 NP