BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROMAX-PLUS MOTOR ASSY

    MDR report key: 3020866 · Received March 18, 2013

    Report

    Report Number
    1045834-2013-00728
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    July 20, 2012
    Report Date
    August 3, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE EVENT DID NOT OCCUR DURING SURGERY. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THE DEVICE WAS "MAKING A HISSING SOUND." THE DEVICE WAS BEING USED DURING SURGERY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THE DEVICE WAS "MAKING A HISSING SOUND". THE INCIDENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT THEREFORE PATIENT INJURY OR MEDICAL INTERVENTION DID NOT OCCUR. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112812 MICROMAX-PLUS MOTOR ASSY ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1