BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY PERINATAL (QUANTITATIVE SENTINEL)

    MDR report key: 1140595 · Received August 28, 2008

    Report

    Report Number
    3004526608-2008-00060
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 2008
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Product Code
    HGM
    PMA / PMN Number
    K993008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP MDR WILL BE SUBMITTED WHEN THE DEVICE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    REGISTERED NURSE REPORTED A PERFORMANCE DEGRADATION IN THE CENTRICITY PERINATAL SYSTEM THAT PREVENTED TIMELY ACCESS TO DATA REQUIRED FOR PATIENT CARE. THERE WAS NO REPORT OF PATIENT IMPACT OR ADVERSE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRICITY PERINATAL (QUANTITATIVE SENTINEL) CENTRICITY PERINATAL HGM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1