BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2131805 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00335
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DPS
    PMA / PMN Number
    K024278
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 WAS UNABLE TO DUPLICATE THE REPORTED EVENT, NO ANOMALIES WERE FOUND DURING FUNCTIONAL TESTING, HOWEVER, THE FIRMWARE NEEDED TO BE UPDATED TO PASS FIRMWARE TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE USB MODULE DOES NOT WORK OR EVEN LIGHT UP. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU ASKU DPS MEDTRONIC MILACA INC. P127 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other