BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2043218 · Received March 15, 2011

    Report

    Report Number
    1218950-2011-00698
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THEY WERE UNABLE TO OBTAIN A READING FROM THE INTRA-UTERINE PRESSURE SENSORS THAT WERE BEING USED ON A PT. THE HOSPITAL'S SAFETY ALERTS COORDINATOR STATED THAT THIS DID NOT RESULT IN ANY PT HARM. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THEY WERE UNABLE TO OBTAIN A READING FROM THE INTRA-UTERINE PRESSURE SENSORS THAT WERE BEING USED ON A PT. THE HOSPITAL'S SAFETY ALERTS COORDINATOR STATED THAT THIS DID NOT RESULT IN ANY PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NA MKJ PHILIPS HEALTHCARE M1333A 101055

    Patients

    Seq Age Sex Outcome Treatment
    1