BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE PATIENT NET

    MDR report key: 2326826 · Received November 1, 2011

    Report

    Report Number
    MW5022947
    Event Type
    Injury
    Date Received
    November 1, 2011
    Date of Event
    October 27, 2011
    Report Date
    November 1, 2011
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A PHYSICIAN'S ORDER FOR CONTINUOUS ELECTROCARDIOGRAM (ECG) AND PULSE OXIMETRY (SPO2) MONITORING. THIS MONITORING WAS VIEWED ON GE'S APEX PRO CLINICAL INFO CENTER (CIC) LOCATED ON THE ACUTE CARE UNIT AND ALSO CONTINUOUSLY MONITORED BY A MONITORING TECHNICIAN IN THE TELEMETRY MONITORING UNIT (TMU). AT THE TIME OF THE OCCURRENCE, THE SPO2 READING DISAPPEARED FROM PT WINDOW ON CENTRAL INFO CENTER (CIC) FOR BOTH THE UNIT AND THE TMU. THE DISAPPEARANCE OF THE READING DOES NOT CAUSE AN ALARM TO SOUND AND IS NOT HIGHLIGHTED ON THE VIEWING SCREEN. IN THE LOCATION WHERE THE SPO2 READING HAD BEEN, THE TRANSCEIVER "TX" NUMBER IS VIEWABLE AS IF THE XPOD CABLE FOR THE SPO2 PROBE HAD BEEN DISCONNECTED. UPON VISUALIZATION OF GE'S DT-4500 FH TELEMETRY TRANSCEIVER, THE PULSE OXIMETRY PROBE LED LIGHT WAS ILLUMINATED AND THE XPOD CABLE TO THE SPO2 PORT WAS SECURELY IN PLACE. THE XPOD CABLE WAS REPLACED WITH A NEW CABLE WITHOUT RESOLUTION TO THE PROBLEM. THE TRANSCEIVER WAS REPLACED WITH A DIFFERENT TRANSCEIVER AND IMMEDIATELY BOTH THE ECG AND THE SPO2 READING WERE RE-ESTABLISHED WITH THE CIC FOR BOTH UNIT AND TMU. THE TRANSCEIVER WAS SET ASIDE FOR TESTING BY GE. UPON FURTHER TROUBLESHOOTING, IF THE BATTERY IS REMOVED AND REPLACED, THE TRANSCEIVER WILL RESET ITSELF AND THE SPO2 READING WILL REAPPEAR AND NORMAL OPERATION IS RESTORED. THIS WORKAROUND DOES NOT HOWEVER ALERT CAREGIVERS OF WHEN THE TRANSCEIVER WILL STOP READING THE SPO2. GE HAS BEEN NOTIFIED AND HAS SUPPLIED RESOURCES NEEDED TO DETERMINE THE ROOT CAUSE OF THIS ISSUE. NO ADVERSE PT OUTCOME. OF NOTE, THE GE TELEMETRY TRANSCEIVER THAT IS THE SUBJECT OF THIS REPORT, WAS ISSUED BY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE PATIENT NET TELEMETRY TRANSCEIVER MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DT-4500 FH

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR