BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAP B650

    MDR report key: 4092871 · Received August 21, 2014

    Report

    Report Number
    9610105-2014-00015
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    GE HEALTHCARE FINLAND OY,
    Product Code
    MHX
    PMA / PMN Number
    K102239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DATA NOT CURRENTLY AVAILABLE. E-MAIL ADDRESS OF REPORTER IS UNKNOWN. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE MONITOR LOGS PROVIDED DO NOT SUPPORT THE INCIDENT DESCRIPTION, DO NOT COVER THE TIME OF INCIDENT OR THE INCIDENT TIME IS INCORRECT. THE ONLY ADDITIONAL INFORMATION PROVIDED WAS THAT THE PROBLEM OCCURRED BEFORE (B)(6) 2014 14:43:56. IT WAS NOT POSSIBLE TO GET A MORE EXACT TIME FROM THE CUSTOMER. THE PROBLEM HAS NOT OCCURRED AGAIN. THE MONITOR LOGS PROVIDED DID NOT INCLUDE ANY RED (HIGH) SPO2 ALARMS IN THE LOGS DURING SEVERAL NEAREST MONTHS. ALSO, THE USER HAS NOT SILENCED ANY ALARMS AT THIS BED DURING (B)(6), WHICH ACCORDING TO DESCRIPTION WAS THE DAY OF INCIDENT. THE AVAILABLE DATA IS INSUFFICIENT AND DOES NOT SUPPORT THE ISSUE DESCRIPTION. ROOT CAUSE REMAINS UNDETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SPO2 ALARM CHANGED FROM A HIGH PRIORITY (RED) ALARM TO A LOW PRIORITY (BLUE) ALARM AFTER THE USER SILENCED THE ALARM AT THE BEDSIDE MONITOR AND THE ALARM STAYED AT A HIGHER PRIORITY (RED) LEVEL AT THE CENTRAL STATION. THIS WAS CORRECTED BY DISCHARGING AND RE-ADMITTING THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504943 CARESCAP B650 MONITOR, PHYSIOLOGICAL, PATIENT MHX GE HEALTHCARE FINLAND OY,

    Patients

    Seq Age Sex Outcome Treatment
    1