BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESCAPE B650

    MDR report key: 5173883 · Received October 24, 2015

    Report

    Report Number
    9610105-2015-00011
    Event Type
    Injury
    Date Received
    October 24, 2015
    Date of Event
    September 23, 2015
    Report Date
    September 24, 2015
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    MHX
    PMA / PMN Number
    K131223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARESCAPE B650 AND ACCESSORIES (NON-GE) WERE TESTED BY THE FIELD SERVICE ENGINEER AND THE DEVICE WAS FUNCTIONING IN ACCORDANCE WITH SPECIFICATIONS. NO ECG PRINTOUTS OF THE PRESUMED ASYSTOLE EVENT, NOR VITAL SIGNS TREND DATA WERE AVAILABLE FOR GE HEALTHCARE REVIEW; THEREFORE, IT COULD NOT BE CONFIRMED IF THE PATIENT¿S ECG WAVEFORM MET THE ALARM CRITERIA FOR AN ASYSTOLE ALARM. LOG FILES WERE REVIEWED BY GE HEALTHCARE ENGINEERING, WHICH SHOWED THAT MULTIPLE SPO2 LOW ALARMS WERE PROVIDED FOR THIS PATIENT DURING THE TIME OF THE EVENT. IN ADDITION, NIBP LOW ALARMS WERE PROVIDED AT MEDIUM-LEVEL WITH THE LAST MEASUREMENT (35/16) ESCALATING TO HIGH. FURTHERMORE, A MEDIUM-LEVEL PAUSE ALARM AND HIGH-LEVEL BRADY ALARM WERE ALSO PROVIDED. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THE INVESTIGATION CONCLUDED THAT, DUE TO THE LACK OF ECG RECORDINGS, THE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, NO DEVICE MALFUNCTION WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE¿S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED AFTER THE INVESTIGATION HAS BEEN COMPLETED. PATIENT DATA NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. INITIAL REPORTER DATA NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT BEING MONITORED ON THE CARESCAPE B650 WAS IN ASYSTOLE AND NO ALARM WAS PROVIDED. THE PATIENT HAD AN INTERNAL PACEMAKER AND THE HOSPITAL REPORTED THE MONITOR WAS DISPLAYING A HEART RATE OF 60 BEATS PER MINUTE AND PACER SPIKES WERE PRESENT. THE PATIENT WAS RESUSCITATED AND SURVIVED THE EVENT. THE HOSPITAL DID NOT ALLEGE THAT THIS ISSUE CAUSED OR CONTRIBUTED TO THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703153 CARESCAPE B650 PHYSIOLOGICAL PATIENT MONITOR MHX GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other