BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AL-III W/FOOT CONTROL

    MDR report key: 3012928 · Received March 1, 2013

    Report

    Report Number
    1045834-2013-00462
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 31, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND WOULD NOT CONNECT IN TO THE AUTOLUBE. THIS IS MOST LIKELY DUE TO THE USAGE/WEAR OVER TIME. THE EVENT WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT DURING SURGERY "THE HOSE WOULD NOT STAY IN THE DEVICE; IT KEPT POPPING OUT." THERE WAS A 15 MINUTE DELAY IN SURGERY TO SWITCH OUT THE DEVICE. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89990 AL-III W/FOOT CONTROL GEY THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1