BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 MOTOR

    MDR report key: 3102580 · Received May 1, 2013

    Report

    Report Number
    1045834-2013-02073
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 4, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE MOTOR DEVICE WAS EVALUATED AND PASSED ALL MFG SPECIFICATIONS. THE REPORTED CONDITION COULD NOT BE CONFIRMED. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT DURING AN EAR SURGERY, THE MOTOR DEVICE "WOULD NOT TURN." THERE WAS A TEN MIN DELAY TO THE SURGERY DUE TO GETTING ANOTHER IDENTICAL MOTOR DEVICE READY FOR USE. THE REPORTER STATED THAT THERE WERE NO INJURIES REPORTED. THE REPORTER STATED THAT PT INFO WOULD NOT BE PROVIDED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190268 EMAX 2 MOTOR HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1