BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXON COMPUTER NOTEBOOK

    MDR report key: 3113314 · Received May 15, 2013

    Report

    Report Number
    1030489-2013-01700
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    GWF
    PMA / PMN Number
    K061639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER: (B)(4), LOT NUMBER: 68068853H ,THE SERIAL NUMBER NOTED WAS PROVIDED BY THE CUSTOMER, BUT IS NOT VALID. DEVICE RECEIVED ON JULY 17 2013, FOR EVALUATION. INFORMATION RECEIVED ON JULY 22, 2013. EVALUATION SUMMARY: PRODUCT ANALYSIS FOR THE 945NCCPU NOTEBOOK (S/N (B)(4)) FOUND THAT THE HARD DRIVE WAS CORRUPT. THE HARD DRIVE WAS RE-IMAGED AND THE LAPTOP TESTED. THE LAPTOP PASSED MANUFACTURING SPECIFICATIONS. NOT A SINGLE USE DEVICE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS NOT RETURNED AND THEREFORE NO EVALUATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE A COMPUTER NOTEBOOK WAS RUNNING SLOW AND LOCKED UP ON SURGEON DIRECTED. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215743 AXON COMPUTER NOTEBOOK STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED, INC 945NCCPU 68068853H

    Patients

    Seq Age Sex Outcome Treatment
    1