BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1698304 · Received May 25, 2010

    Report

    Report Number
    1056128-2010-00022
    Event Type
    Malfunction
    Date Received
    May 25, 2010
    Date of Event
    April 26, 2010
    Report Date
    July 15, 2010
    Manufacturer
    ASCENT HALTHCARE SOLUTIONS
    Product Code
    NMF
    PMA / PMN Number
    K011832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT THE DEVICE INVESTIGATION HAS NOT BEEN COMPLETED. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT REMAIN INFLATED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NMF NMF ASCENT HALTHCARE SOLUTIONS 11165 878439

    Patients

    Seq Age Sex Outcome Treatment
    1