BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY ACUTE CARE SYSTEM (M540)

    MDR report key: 7112635 · Received December 13, 2017

    Report

    Report Number
    1220063-2017-00064
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 2, 2017
    Report Date
    January 12, 2018
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K113798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT WAS RECEIVED REGARDING A SPO2 SATURATION READING OF 100% WITH THE SPO2 SENSOR NOT/PARTIALLY CONNECTED. NO SPO2 FAILURE ENTRIES WERE IN THE M540 LOGS. THE CITED M540, SPO2 POD, AND SPO2 INTERMEDIATE CABLE WERE SENT FOR INVESTIGATION. THE CITED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP 2 WAS SENT AS PART OF THE DESCRIPTION OF THE EVENT/PROBLEM AND ADDITIONAL MANUFACTURER NARRATIVE WAS CUT OFF IN THE XML. A COMPLAINT WAS RECEIVED REGARDING A SPO2 SATURATION READING OF 100% WITH THE SPO2 SENSOR NOT/PARTIALLY CONNECTED. NO SPO2 FAILURE ENTRIES WERE IN THE M540 LOGS. THE CITED M540, SPO2 POD, AND SPO2 INTERMEDIATE CABLE WERE SENT FOR INVESTIGATION. THE CITED SPO2 DISPOSABLE SENSOR WAS REQUESTED BUT WAS NOT AVAILABLE FOR INVESTIGATION. AFTER TESTING THE RETURNED MATERIAL WITH A PREVIOUSLY UNOPENED DISPOSABLE SPO2 SENSOR, IT WAS FOUND THAT THE DEVICE FUNCTIONED AS DESIGNED. NO FAILURE COULD BE VERIFIED WITH THE RETURNED MATERIAL. THE NELLCOR SENSOR IFU STATES HOW TO CORRECTLY APPLY THE SENSOR TO THE PATIENT. THE NELLCOR SENSOR IFU CAUTIONS THE USER OF POSSIBLE CAUSES OF INCORRECT MEASUREMENTS.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS STARTED. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IACS PATIENT MONITOR SHOWED SP02 OF 100% WITH SP02 PROBE NOT/PARTIALLY ATTACHED TO PATIENT. THE IACS HDU07 WAS MONITORING A COPD PATIENT WITH SPO2 VALUES OF 90 - 93%. AT APPROX. 4:45AM ON (B)(6) 2017 STAFF NOTICED IACS DISPLAYING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IACS PATIENT MONITOR SHOWED SP02 OF 100% WITH SP02 PROBE NOT/PARTIALLY ATTACHED TO PATIENT. THE IACS HDU07 WAS MONITORING A COPD PATIENT WITH SPO2 VALUES OF 90 - 93%. AT APPROX. 4:45AM ON (B)(6) 2017 STAFF NOTICED IACS DISPLAYING SP02 OF 100%.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IACS PATIENT MONITOR SHOWED SP02 OF 100% WITH SP02 PROBE NOT/PARTIALLY ATTACHED TO PATIENT. THE IACS HDU07 WAS MONITORING A COPD PATIENT WITH SPO2 VALUES OF 90 - 93%. AT APPROX. 4:45AM ON (B)(6) 2017 STAFF NOTICED IACS DISPLAYING SP02 OF 100%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891881 INFINITY ACUTE CARE SYSTEM (M540) PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT CBK DRAEGER MEDICAL SYSTEMS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1