BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW SL PATIENT MONITOR

    MDR report key: 1902795 · Received November 11, 2010

    Report

    Report Number
    3023361-2010-00073
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 11, 2010
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K972282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSP REPORTED THEY OBSERVED A FLAT LINE ON THE MONITOR AND THAT AFTER CHECKING THE ELECTRODES AND LEAD WIRES, THE SIGNAL RETURNED. A REVIEW OF THE PATIENT'S WAVEFORM HISTORY SHOWED THAT THE EVENT WAS PRECEDED BY A NOISY SIGNAL WITH A WANDERING BASELINE THAT THEN BECAME A FLAT LINE. THIS DATA ALSO THAT "??" WAS DISPLAYED FOR HEART RATE INDICATING THAT THE SIGNAL QUALITY WAS QUESTIONABLE. SPACELABS OBSERVED THAT THIS PATIENT WAS BEING MONITORED USING UNSHIELDED LEAD WIRES RATHER THAN THE SPACELABS SHIELDED LEAD WIRES. SPACELABS INFORMED THE HOSPITAL THAT THESE WIRES ARE NOT RECOMMENDED AND COULD HAVE CONTRIBUTED TO THE NOISY SIGNAL. TESTING OF AVAILABLE, SPARE LEAD WIRES, PERFORMED BY THE HOSPITAL BIOMED, CONFIRMED UNSHIELDED LEAD WIRES MIXED IN WITH THE SPACELABS LEAD WIRES AND ALSO CONFIRMED TWO DEFECTIVE UNSHIELDED LEAD WIRES IN THE GROUP. TESTING OF THE INCIDENT MONITOR WAS LIMITED DUE TO IT CONTINUING TO BE USE TO MONITOR THE PATIENT. LIMITED TESTING VERIFIED ALARM FUNCTIONALITY AND COMPLIANCE WITH SPECIFICATION. NO ONE HAS BEEN INJURED AS A RESULT OF THIS CONDITION. THE HOSP IS CONTINUING TO USE THE EQUIPMENT. THE CONDITION REPORTED APPEARS TO BE THE RESULT OF USING UNSHIELDED LEAD WIRES INSTEAD OF THE SPACELABS RECOMMENDED SHIELDED LEAD WIRES. THE HOSP HAS BEEN ADVISED TO USE ONLY SPACELABS APPROVED PATIENT CABLES AND LEAD WIRES. WE HAVE CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AND CONSIDER THIS ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT MONITOR FAILED TO ALARM IN ASYSTOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS ULTRAVIEW SL PATIENT MONITOR MULTIPARAMETER PATIENT MONITOR DSI SPACELABS HEALTHCARE 91387

    Patients

    Seq Age Sex Outcome Treatment
    1