BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS ULTRAVIEW PATIENT MONITOR

    MDR report key: 3931247 · Received June 20, 2014

    Report

    Report Number
    3010157426-2014-00040
    Event Type
    Death
    Date Received
    June 20, 2014
    Date of Event
    March 10, 2014
    Report Date
    September 11, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K102422
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THE PATIENT¿S CARDIAC RHYTHM CHANGED FROM SINUS TACHYCARDIA TO JUNCTIONAL RHYTHM AT 11:08 PM ON (B)(6) 2014 AND THEN CHANGED TO ACCELERATED IDIOVENTRICULAR RHYTHM (AIVR) WITH HEART RATE IN THE 50¿S AT 11: 17 PM. ACCORDING TO THE CUSTOMER, THE TELEMETRY CENTRAL MONITOR NEVER ALARMED. A SPACELABS FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER¿S SITE TO CONDUCT THE INVESTIGATION AND COLLECT THE PATIENT¿S DATA. THE MONITOR WAS IN USE ON OTHER PATIENTS. THE CUSTOMER DID NOT ALLOW THE FSE TO TEST ANY DEVICE. WE REVIEWED THE FULL DISCLOSURE DATABASE (ICS) AND PATIENT¿S ECG STRIPS THAT WERE PROVIDED BY THE CUSTOMER. THE SIX ECG STRIPS INDICATE THAT THE JUNCTIONAL RHYTHM BEGAN AT 11:08 PM AND ENDED AT 11:13PM ON (B)(6) 2014. THE HEART RATE VARIED BETWEEN 52 -67 BEATS PER MINUTE (BPM). THE TWO ECG STRIPS INDICATE THAT THE ACCELERATED IDIOVENTRICULAR RHYTHM (AIVR) BEGAN AT 11:28:12PM AND ENDED AT 11:33:56 PM WITH HEART RATE 52 BPM. THE ALARM REVIEW TAB OF ICS DATABASE SHOWS THE MODULE WAS SET WITH RUN ALARM ON, ECG HI LIMIT = 130 BEATS PER MINUTE (BPM) AND ECG LOW LIMIT = 50 BPM. AS THE ECG LOW LIMIT WAS SET TO 50 BPM, THE HEART RATE OF 52-67 BPM WOULD NOT TRIGGER AN ALARM DURING THE EVENTS DEPICTED IN THE WAVEFORM STRIPS. THE SPACELABS MONITOR DOES NOT HAVE A DETECTOR FOR JUNCTIONAL RHYTHMS AND AIVR. THE EVENTS THAT THE MONITOR WILL DETECT AND ALARM FOR ARE IDENTIFIED IN THE USER MANUAL. ON THE BASIS OF OUR INVESTIGATION, WE HAVE CONCLUDED THAT THE TELEMETRY SYSTEM DID NOT MALFUNCTION. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THA PT'S CONDITIONS WERE CHANGED FROM SINUS TACHYCARDIA TO JUNCTIONAL RHYTHM AT 11:08PM, AND THEN CHANGED TO ACCELERATED IDIOVENTRICULAR RHYTHM (AIVR) WITH HEART RAT IN THE 50'S AT 11:17PM. THE MONITOR NEVER ALARMED. A SPACELABS FIELD SERVICE ENGINEER VISITED THE CUSTOMER'S SITE TO CONDUCT THE INVESTIGATION AND COLLECT THE PT'S DATA. THE CUSTOMER WAS UNABLE TO SECURE THE INCIDENT TRANSMITTER THEREFORE NO TESTING WAS DONE. THE RETROSPECTIVE DATABASE WAS RETURNED TO SPACELABS FOR INVESTIGATION. WE WILL FILE A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS CONCLUDED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A TELEMETRY PT MONITOR FAILED TO ALARM FOR VARIOUS PT CONDITIONS. THE PT DIED AFTER BEING CODED FOR ABOUT 27 MINUTES.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A TELEMETRY CENTRAL MONITOR FAILED TO ALARM FOR VARIOUS PATIENT CONDITIONS. THE PATIENT DIED AFTER BEING CODED FOR ABOUT 27 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364262 SPACELABS ULTRAVIEW PATIENT MONITOR MULTIPARAMETER PATIENT MONITOR MHX SPACELABS HEALTHCARE INC. 91387

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death 91387-38 (UNKNOWN)