BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS ULTRAVIEW SL2400 COMPACT MONITOR

    MDR report key: 6133151 · Received November 29, 2016

    Report

    Report Number
    3010157426-2016-00189
    Event Type
    Death
    Date Received
    November 29, 2016
    Date of Event
    October 18, 2016
    Report Date
    January 10, 2017
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K102422
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS HAS LAUNCHED AN INVESTIGATION AND WILL FILE A SUPPLEMENTAL REPORT ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S HISTORICAL DATA AND TREND INFORMATION WAS REVIEWED BY A SPACELABS LEAD SOFTWARE ENGINEER. THE ALARM STRIPS CLEARLY SHOW ECG CHANGES TYPICAL OF CARDIAC DISTRESS, INCLUDING DEPRESSED QRS AMPLITUDE IN V5, VENTRICULAR FLUTTER AND VENTRICULAR FIBRILLATION. THERE WAS NO EVIDENCE OF ASYSTOLE IN THE ECG WAVEFORMS. A VERY NOISY SIGNAL WAS NOTED THROUGHOUT 1.5 HOURS CAPTURED IN THE PRINTOUTS. THIS WAS DUE TO AN ISSUE WITH ECG ELECTRODE PLACEMENT. ALTHOUGH THE ECG SIGNAL QUALITY WAS INSUFFICIENT FOR ACCURATE MONITORING OF THE PATIENT¿S CARDIAC RHYTHM, THE MONITOR DID PROVIDE AT LEAST SEVEN ALARMS FOR LOW SPO2 AND AT LEAST TWELVE ECG ALARMS DURING THE COMPLAINT EPISODE. THE DEVICE PERFORMED TO SPECIFICATIONS. THIS REPORT IS CONSIDERED FINAL, AND THE ISSUE IS CLOSED.

    Description of Event or Problem · 1

    ON NOVEMBER 3, 2016 SPACELABS RECEIVED A COPY OF A MATERIOVIGILANCE REPORT FROM (B)(6). THE DOCUMENT RELATED A (B)(6) HOSPITAL¿S REPORT THAT ON THE (B)(6) 2016, A PATIENT EXPERIENCED BLEEDING AND CARDIAC ARREST ONE DAY FOLLOWING MULTIPLE HEART VALVE REPLACEMENT SURGERY. THE DOCUMENT STATED THAT MONITORING INTERFERENCE WAS PRESENT PREVENTING THE ACQUISITION OF THE EGG SIGNAL RESULTING IN A DELAY IN ALERTING PROFESSIONALS TO THE CARDIAC ARREST. THE PATIENT WAS RESUSCITATED, HOWEVER HIS CONDITION WORSENED AND THE PATIENT DIED FROM MULTIPLE ORGAN FAILURE AND CARDIORESPIRATORY ARREST ON THE (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782882 SPACELABS ULTRAVIEW SL2400 COMPACT MONITOR 2400 UVSL PATIENT MONITOR MHX SPACELABS HEALTHCARE INC. 91369

    Patients

    Seq Age Sex Outcome Treatment
    1 Death