BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 2971170 · Received February 1, 2013

    Report

    Report Number
    1045834-2013-00174
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 4, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBE
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. EVIDENCE INDICATES THIS IS DUE TO USAGE WEAR OVER TIME. ADDITIONAL INFORMATION: A REVIEW OF THE DEVICE HISTORY RECORD DID NOT INDICATE ANY CONDITIONS DURING MANUFACTURING OPERATIONS THAT COULD BE RELATED TO THE REPORTED CONDITION. THE ATTACHMENT DEVICE PASSED ALL MANUFACTURING AND TEST REQUIREMENTS AT THE TIME OF MANUFACTURE. A TREND REVIEW INDICATED NO INCREASE IN COMPLAINTS OF THIS NATURE FOR THIS DEVICE. MONITORING WILL BE CONDUCTED FOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. REF: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS "OVERHEATING" DURING TESTING. THE PRODUCT WAS NOT USED IN SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45319 EMAX 2 PLUS MOTOR HBE THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1