BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 1992176 · Received February 15, 2011

    Report

    Report Number
    2183613-2011-00046
    Event Type
    Malfunction
    Date Received
    February 15, 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
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. 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 DEVICE WOULD NOT POWER UP. THE CAUSE WAS THE MAIN PCB (PRINTED CIRCUIT BOARD). THE LOWER CASE AND ONE BAIL COVER WERE ALSO FOUND TO BE BROKEN, THE KEYBOARD SCRATCHED, AND ONE BAIL AND RING BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ATTEMPTING TO POWER ON THE DEVICE, IT LIGHTS UP, MINUS THE ARTERIAL LED. THE GREEN DOES NOT LIGHT UP, THE DEVICE POWERS ON, AND THEN IMMEDIATELY POWERS OFF. IT WON'T TURN ON AND MAY HAVE BEEN SUBMERGED OR DROPPED. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

    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