BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLAR

    MDR report key: 3874053 · Received May 19, 2014

    Report

    Report Number
    3874053
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    March 26, 2013
    Report Date
    May 19, 2014
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    (B)(6) YEAR OLD WOMAN WITH CEREBRAL HEMORRHAGE WAS ON MECHANICAL VENTILATION. AROUND MIDNIGHT, THE RN CALLED A CODE BLUE BECAUSE THE MONITOR INDICATED A HR IN THE 20'S - 30'S FOR ABOUT A 7-MINUTE PERIOD. THE RHYTHM IS 100% VENTRICULAR PACING WITH NO EVIDENCE OF PACER MALFUNCTION (E.G. NON-CAPTURE). AT THE SAME TIME, THE HR DETECTED FROM THE SPO2 SENSOR INDICATED 70 BPM WITH SPO2 100% WITH PULSATILE WAVEFORM MATCHING PACING RATE. THE NURSE FOCUSED ON THE MONITOR'S HR NUMBER; COMMUNICATION WITH THE PATIENT WAS NOT POSSIBLE BECAUSE OF HER NEUROLOGICAL STATUS AND THE FACT THAT SHE WAS INTUBATED, ON MECHANICAL VENTILATION. THIS EVENT USED HOSPITAL RESOURCES UNNECESSARILY BUT CAUSED NO HARM TO THE PATIENT.APPARENTLY THE PATIENT'S ECG HAD A LOW AMPLITUDE AND CAUSED THE BEDSIDE MONITOR TO UNDERCOUNT THE HEART RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296045 SOLAR MONITOR MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 8000I *
    296046 N MONITOR MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 2016793 *

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR PACEMAKER