BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 3941272 · Received July 17, 2014

    Report

    Report Number
    2015691-2014-01604
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT A PRODUCT RETURN, NOR COULD POTENTIAL CONTRIBUTING FACTORS BE IDENTIFIED. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DPT WAS GIVING INACCURATE VALUES. THE PRESSURE READINGS THAT WERE RECEIVED WERE OUTSIDE OF THE VALUE LIMITS THAT WERE EXPECTED. ABERRANT VALUES WERE NOTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418516 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR T100209A

    Patients

    Seq Age Sex Outcome Treatment
    1