BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICS INFINITY CENTRAL STATION

    MDR report key: 4788267 · Received May 19, 2015

    Report

    Report Number
    1220063-2015-00011
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 21, 2015
    Report Date
    April 22, 2015
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER MEDICAL HAS ANALYZED THE LOG FILES. IT IS EVIDENT THAT THE INFINITY CENTRAL STATION HAS ALARMED FOR BRADYCARDIA ON EIGHT OCCASIONS DURING THE TWO SEQUENCES IN QUESTION. THE INPUT RECORDER SHOWS THAT THE USER HAS SUPPRESSED THE ACOUSTICAL ALARMS REPEATEDLY OF MEDIUM GRADE ALARMS LIKE HR LOW. SPO2 LOW AND RR HIGH WERE POSTED FROM THE BEDSIDE MONITOR. DURING PEA, THERE IS CARDIAC ELECTRICAL ACTIVITY. THUS, IT MAY HAPPEN IN INDIVIDUAL SITUATIONS OF OCCURRENCE THAT NO ECG ALARMS ARE BEING POSTED. AS LONG AS IBP. SPO2 OR OTHER VITAL PARAMETERS ARE BEING MONITORED, THE DETECTION OF PEA IS ENSURED. FOR THE PARTICULAR CASE, THE IACS ALGORITHM HAD ASSOCIATED THE PEA WITH BRADYCARDIA AND ALARMED FOR IT APPROPRIATELY. ADDITIONALLY, EXCEEDING THE ALARM THRESHOLDS FOR OTHER VITAL PARAMETERS WAS ALERTED AS WELL AND ACKNOWLEDGED BY THE USER. DRAEGER MEDICAL FINALLY CONCLUDES THAT THE DEVICE WORKED AS INTENDED DURING THE CONCERNED MONITORING EPISODE AND THUS, THE COMPLAINT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL NURSING STAFF THAT THE PT IN ROOM (B)(6) WENT INTO "PEA ARREST" (PULSELESS ELECTRICAL ACTIVITY CARDIAC ARREST) AT APPROXIMATELY 12:30 HOURS AND BRADYCARDIA AT APPROXIMATELY 18:39 HOURS ON (B)(6) 2015. THEY REPORTED THAT THE ICS (INFINITY CENTRAL STATION) DID NOT ALARM FOR THESE EVENTS. THEY DID NOT KNOW IV GHD IACS (INFINITY ACUTE CARE SYSTEM) ALARMED OR NOT. THE ALARM REVIEW DID NOT GO BACK FARE ENOUGH FOR IACS. BUT THERE REPORTEDLY WERE BRADY EVENTS IN THE ICS AROUND THESE TIMES. THERE WAS NO PT INJURY REPORTED. DRAEGER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324106 ICS INFINITY CENTRAL STATION PATIENT MONITORING SYSTEM MHX DRAEGER MEDICAL SYSTEMS, INC. MS25707 NA

    Patients

    Seq Age Sex Outcome Treatment
    1