BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2132017 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00228
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT REGARDING THE MAIN PC BOARD BEING OUT OF SPECIFICATION. IT WAS ALSO NOTED THAT THE UPPER CASE WAS BROKEN AND THE LOWER CASE WAS CONTAMINATED. ALSO, THE RING COVER WAS CONTAMINATED AND TWO SIDE BAIL COVERS ARE BROKEN. ALSO THE RING IS BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING BIOMED TESTING THE DEVICE WAS FOUND TO HAVE NO VENTRICULAR OUTPUT. THE DEVICE WAS SENT IN FOR REPAIR. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other