BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3102496 · Received May 2, 2013

    Report

    Report Number
    1045834-2013-02076
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE MOTOR DEVICE WAS TESTED AND PASSED ALL MFG SPECIFICATIONS. THE REPORTED CONDITION WAS NOT 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 THERE WAS AN "AIR LEAK IN THE HOSE" OF THE MOTOR DEVICE. THE REPORTER STATED THAT THE AIR LEAK WAS NOTICED WHILE TESTING THE MOTOR DEVICE BEFORE SURGERY. THE REPORTER STATED THAT THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192974 XMAX MOTOR ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1