BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS ULTRAVIEW PATIENT MONITOR

    MDR report key: 3931265 · Received June 20, 2014

    Report

    Report Number
    3010157426-2014-00029
    Event Type
    Death
    Date Received
    June 20, 2014
    Date of Event
    March 5, 2014
    Report Date
    November 20, 2014
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K102422
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A NURSE FROM THE FACILITY REPORTED THAT SHE WAS ¿UNSATISFIED¿ WITH THE TELEMETRY ALARM AND THAT THE ALARM MESSAGE DID NOT GET TO THE MONITOR TECH WHEN THE PATIENT WENT INTO VFIB. THE PATIENT WAS ON A TELEMETRY TRANSMITTER (MODEL 91343) WHICH SENDS ECG SIGNALS TO THE TELEMETRY RECEIVER MODULE (MODEL 90478). THE ECG ALGORITHM LOCATED IN THE TELEMETRY RECEIVER MODULE PROCESSES ECG SIGNALS AND DETERMINES ALARM STATUS SENDING ALARM MESSAGES FOR DISPLAY TO THE TELEMETRY CENTRAL MONITOR (MODEL 91387-38). IT IS UNCLEAR FROM THE INFORMATION PROVIDED IF THE MONITOR TECH WAS OBSERVING THE TELEMETRY CENTRAL MONITOR OR VIEWING THE ALARM MESSAGES REMOTELY THROUGH A SECONDARY MONITOR. ONSITE TESTING OF THE INVOLVED DEVICES PERFORMED ON (B)(4) 2014 BY A SPACELABS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE EQUIPMENT WORKED TO SPECIFICATIONS. THE CUSTOMER DECLINED TO WITNESS THE TESTING. THE FSE WAS TOLD THE PATIENT WAS IN ROOM (B)(6) AND THE EVENT OCCURRED ¿SOMETIME ON (B)(6) 2014.¿ RETROSPECTIVE PATIENT DATA PROVIDED BY THE CUSTOMER WAS REVIEWED BY A SPACELABS LEAD SOFTWARE ENGINEER. THE DATA CONTAINED A DIFFERENT BED NUMBER AND NO EVIDENCE OF VFIB FOR THE EVENT DATE. THE FSE ATTEMPTED TO CONTACT THE CUSTOMER ON (B)(4) TO CLARIFY THE DATA. THE ONLY ADDITIONAL CUSTOMER INFORMATION CAME FROM THE FSE¿S (B)(4) 2014 PHONE CALL AT WHICH TIME THE CUSTOMER STATED THE EQUIPMENT WAS IN USE ON ANOTHER PATIENT AND THE EVENT IN QUESTION MAY NOT HAVE BEEN THE RESULT OF DEVICE MALFUNCTION. THE CUSTOMER DECLINED ANY ADDITIONAL INFORMATION OR TO CLARIFY THE RETROSPECTIVE DATA; THEREFORE, ROOT CAUSE COULD NOT BE DETERMINED. IN CONCLUSION, DUE TO LACK OF DATA FROM THE CUSTOMER FOR THE PATIENT INVOLVED IN THE INCIDENT, WE CANNOT CONCLUSIVELY DETERMINE CAUSE OF THE REPORTED FAILURE. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A SPACELABS FIELD SERVICE ENGINEER VISITED THE CUSTOMER AND FOUND THAT THE SUBJECT DEVICES WERE STILL BEING USED TO MONITOR PATIENTS. THE DEVICES WERE TESTED ONSITE AND PASSED ALL FUNCTIONAL TESTS OUTLINED IN THE SERVICE MANUAL. THE FSE WAS UNABLE TO DUPLICATE THE ALLEGED FAILURE TO ALARM. A RETROSPECTIVE DATABASE WAS PROVIDED BY THE CUSTOMER FOR EVALUATION. A SPACELABS ENGINEER IS CURRENTLY ANALYZING THE PT DATA TO IDENTIFY THE ROOT CAUSE. THE INVESTIGATION IS UNDERWAY. WE WILL FILE A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS CONCLUDED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A TELEMETRY CENTRAL MONITOR FAILED TO ALARM FOR A PATIENT EPISODE OF VENTRICULAR FIBRILLATION (VFIB). THE PATIENT PASSED AWAY SUBSEQUENT TO THIS EVENT.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A TELEMETRY MONITOR FAILED TO ALARM. THE PT WENT INTO VENTRICULAR FIBRILLATION (VFIB) AND PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364276 SPACELABS ULTRAVIEW PATIENT MONITOR MULTIPARAMETER PATIENT MONITOR MHX SPACELABS HEALTHCARE INC. 91387

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (B)(4)| TELEMETRY TRANSMITTERS MODEL 91343