BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE MONITOR B850

    MDR report key: 2160301 · Received April 28, 2011

    Report

    Report Number
    2124823-2011-00054
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 28, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K092027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER (B)(6) LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. THIS ISSUE AFFECTS THE PARAMETER ALARM PRIORITY FOR HEART RATE, PULSE OXIMETRY, AND INVASIVE BLOOD PRESSURE. RECURRENCE OF THIS ISSUE COULD RESULT IN DELAYED CAREGIVER RESPONSE TO A HR, SP02, OR IBP ALARM. THE ALARM STILL OCCURS, BUT MAY ALARM AT LOW PRIORITY. LOW PRIORITY ALARMS HAVE A SINGLE BRIEF AUDIO TONE AND A PERSISTENT VISUAL ALERT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARESCAPE B850 HEART RATE ALARM PRIORITY, MAY INADVERTENTLY CHANGE FROM ESCALATING PRIORITY TO LOW PRIORITY, WHEN THE USER CHANGES THE HEART RATE LIMIT AT THE ICENTRAL. THERE WAS NO DEATH, SERIOUS INJURY, OR DELAY IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESCAPE MONITOR B850 MULTI-PARAMETER PATIENT MONITOR MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1