BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREMETRICS MODEL 757 AUDIOMETER

    MDR report key: 1927117 · Received December 9, 2010

    Report

    Report Number
    MW5018550
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    TREMETRICS
    Product Code
    EWO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    (B)(6) HAS 540 TREMETRICS AUDIOMETERS, MODEL 757, THAT HAVE PRINTERS THAT WORK SPORADICALLY, TOUCH SCREEN FAILURES, HEADPHONE PROBLEMS, AND SOFTWARE ISSUES. A (B)(6) 2010 UPGRADE ATTEMPT DID NOT CORRECT THE PROBLEMS. REPAIR IS STILL REQUIRED. THE AUDIOMETERS ARE OUT OF WARRANTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREMETRICS MODEL 757 AUDIOMETER AUDIOMETER EWO TREMETRICS 757

    Patients

    Seq Age Sex Outcome Treatment
    1