BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIDECO ELECTA

    MDR report key: 1842391 · Received September 16, 2010

    Report

    Report Number
    1718850-2010-00151
    Event Type
    Other
    Date Received
    September 16, 2010
    Product Code
    CAC
    PMA / PMN Number
    K020647
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) RECEIVED A MEDWATCH REPORT, (B)(4), STATING THAT THE CELL SAVER MACHINE MALFUNCTIONED. SORIN GROUP (B)(4) MANUFACTURES THE ELECTA AUTOTRANSFUSION MACHINE. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). RISK MANAGEMENT WAS CONTACTED AND STATED THAT THERE WERE NO PATIENT ISSUES. THE ELECTA HAS BEEN RETURNED TO SORIN GROUP (B)(4) FOR EVALUATION. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIDECO ELECTA NONE CAC 75210

    Patients

    Seq Age Sex Outcome Treatment
    1