BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY ACUTE CARE SYSTEM (M540)

    MDR report key: 5495774 · Received March 11, 2016

    Report

    Report Number
    1220063-2016-00010
    Event Type
    Malfunction
    Date Received
    March 11, 2016
    Date of Event
    February 6, 2016
    Report Date
    March 11, 2016
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K113798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    LOG FILES OF THE AFFECTED M540 AND SCREENSHOTS WERE PROVIDED FOR THE INVESTIGATION. FULL DISCLOSURE AND ECG STRIP REPORTS WERE REQUESTED BUT NOT AVAILABLE AS THE INFORMATION FROM THE TIME OF THE EVENT HAD ALREADY BEEN OVERWRITTEN. THE SCREENSHOTS SHOW A 17 SECONDS TIMEFRAME 50 MINUTES PRIOR TO THE REPORTED EVENT IN WHICH SOME PVC BEATS WERE DETECTED BY THE IACS AND ALARMED BY AN ARRHYTHMIA VENTRICULAR COUPLET ALARM. FURTHERMORE THE SCREENSHOTS AND LOG FILES SHOW THAT THE USER CONFIGURED THE LIMIT FOR A SERIOUS PVC ALARM TO BE MORE THAN 6 PVC/MINUTE. IN ORDER TO DETERMINE IF THE IACS SHOULD HAVE DETECTED A PVC ALARM THE STRIP REPORT IS NECESSARY AS THE SCREENSHOT SHOWING AN EXCERPT ARE NOT SUFFICIENT. SINCE THIS WAS NOT AVAILABLE IT COULD NOT BE CONCLUDED IF THERE WAS ANY SITUATION WHERE THE PATIENT EXPERIENCED MORE THAN 6 PVC/MIN. THE LOG ENTRIES SHOW THAT DURING THE REPORTED TIME OF EVENT MULTIPLE SERIOUS NIBP ALARMS WERE GENERATED. THE ONLY LOGGED PVC ALARMS WERE TWO DAYS PRIOR TO THE EVENT. WHEN THE SERVICE TECHNICIAN TESTED THE M540 AFTER THE EVENT THE MONITOR ALARMED AS EXPECTED FOR THE SIMULATED PVC WAVEFORM. THE AVAILABLE INFORMATION DOES NOT INDICATE ANY SITUATION REQUIRING A PVC ALARM. FURTHERMORE THE IACS HAS BEEN RETURNED TO USE WITHOUT FURTHER ISSUES REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXHIBITED WHAT THE NURSING STAFF IDENTIFIED AS A PVC CONDITION BUT THE IACS DID NOT ALARM VISUALLY OR AUDIBLY FOR THE EVENT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152344 INFINITY ACUTE CARE SYSTEM (M540) PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT CBK DRAEGER MEDICAL SYSTEMS, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1