BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE B850

    MDR report key: 8898178 · Received August 15, 2019

    Report

    Report Number
    3008729547-2019-00007
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 16, 2019
    Report Date
    September 13, 2019
    Manufacturer
    CRITIKON DE MEXICO S. DE R.L. DE C.V.
    Product Code
    MHX
    PMA / PMN Number
    K131414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION FINDINGS: THE CARESCAPE B850 (MANUFACTURED ON FW16, 2010) BEDSIDE PATIENT MONITOR'S POWER SUPPLY WAS EVALUATED BY GE HEALTHCARE ENGINEERING WHICH SHOWED THAT THE DAMAGE WAS LIMITED TO ONE BURNT CAPACITOR, C102, IN THE POWER SUPPLY. CAPACITOR C102 SHOWED SIGNS OF MELTING AND BROWNISH COLOR IN CAPACITOR PLASTIC CASE. THERE WERE SIGNS OF LIGHT BROWN DUST IN THE SURROUNDING WALLS OF THE COOLING PLATES AND NEARBY WALLS OF POWER ON/OFF SWITCH ASSEMBLY. THERE ARE NO SIGNS OF BURNING IN OTHER COMPONENTS EXCEPT CAPACITOR C102. THE CAPACITOR IS COMPOSED OF FLAME RETARDANT MATERIAL. A REVIEW OF HISTORICAL DATA REVEALED NO ADVERSE TREND RELATED TO THE REPORTED ISSUE. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE COULD NOT BE DETERMINED. THIS RECORD WILL BE TRACKED AND TRENDED. IF TREND LIMITS ARE TRIGGERED OR NEW INFORMATION BECOMES AVAILABLE, THE RECORD WILL BE REEVALUATED.

    Additional Manufacturer Narrative · 1

    UDI NOT REQUIRED. LEGAL MANUFACTURER: HCS TOWER (B)(4). NOT APPLICABLE. THERE WAS NO PATIENT CONNECTED TO THE DEVICE AT THE TIME OF THE EVENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE UNITED STATES AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. GE HEALTHCARE'S INVESTIGATION IS ON-GOING AT THIS TIME. THE FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SMOKE WAS EMITTING FROM THE CARESCAPE B850 PATIENT MONITOR. THERE WAS NO RELATED PATIENT CONSEQUENCE NOR WAS THERE A PATIENT CONNECTED TO THE DEVICE AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690136 CARESCAPE B850 MONITOR, PHYSIOLOGICAL, PATIENT (WIT MHX CRITIKON DE MEXICO S. DE R.L. DE C.V. 2042395-001

    Patients

    Seq Age Sex Outcome Treatment
    1