BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2131790 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00332
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 28, 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
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. EVALUATION SUMMARY: (B)(4): ANALYSIS CONFIRMED THE CUSTOMER COMMENT: THE MAIN PRINTED CIRCUIT (PC) BOARD WAS CONTAMINATED AND THE LIQUID CRYSTAL DISPLAY (LCD) WAS OUT OF SPECIFICATION WITH MISSING SEGMENTS. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE CONTAMINATED, THE RING COVER AND TWO SIDE BAIL COVERS WERE BROKEN, THE BATTERY RELEASE, LEAD FLEX COVER, BOARD CONNECTOR CABLES, BATTERY DRAWER AND ENCODER FLEX WERE CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, AND THE RING WAS BENT.

    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): ANALYSIS CONFIRMED THE CUSTOMER COMMENT: THE MAIN PRINTED CIRCUIT (PC) BOARD WAS CONTAMINATED AND THE LIQUID CRYSTAL DISPLAY (LCD) WAS OUT OF SPECIFICATION WITH MISSING SEGMENTS. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE CONTAMINATED, THE RING COVER AND TWO SIDE BAIL COVERS WERE BROKEN, THE BATTERY RELEASE, LEAD FLEX COVER, BOARD CONNECTOR CABLES, BATTERY DRAWER AND ENCODER FLEX WERE CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, AND THE RING WAS BENT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE BIOMEDICAL ENGINEER POWERED ON THE EPG (EXTERNAL PULSE GENERATOR) TO DO A CHECK, IT WOULD NOT POWER ON TO THE DEFAULT SETTINGS, EVEN WITH A NEW BATTERY. THE LED LIGHTS STAYED LIT, THERE WAS ONLY PARTIAL SEGMENTS ON THE DISPLAY, AND ANOTHER LANGUAGE APPEARED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4).

    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