BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLUBE-III

    MDR report key: 3102616 · Received May 1, 2013

    Report

    Report Number
    1045834-2013-02061
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 2, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS TESTED AND THE REPORTED CONDITION WAS DUPLICATED. EVIDENCE INDICATES THIS IS DUE TO USAGE WEAR OVER TIME. THE REPORTED CONDITION WAS CONFIRMED. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. REPORT RECEIVED FROM THE USA STATING THAT THE MOTOR DEVICE, WHEN IN USE WITH A FOOT CONTROL DEVICE, MADE "POPPING SOUNDS" AND THEN AIR CAME OUT OF THE MOTOR DEVICE. THE REPORTER STATED THAT AFTER THE SOUND FROM THE MOTOR DEVICE, IT WAS OBSERVED THAT THE FOOT CONTROL DEVICE HAD "AIR COMING OUT OF THE VENT AREA". THE DEVICES WERE BEING USED IN A HEMI LAMINECTOMY PROCEDURE ON AN ANIMAL PT. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190141 AUTOLUBE-III GEY THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 XMAX (MOTOR DEVICE)