BEUDAMED
    FDA Adverse Event Death Summary report: N

    GE

    MDR report key: 6440511 · Received March 28, 2017

    Report

    Report Number
    6440511
    Event Type
    Death
    Date Received
    March 28, 2017
    Date of Event
    March 15, 2017
    Report Date
    March 23, 2017
    Manufacturer
    GE OAK CREEK
    Product Code
    MHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE ADMITTED WITH COMPLAINTS OF SHORTNESS OF BREATH AND MID EPIGASTRIC ABDOMINAL DISCOMFORT FOR 2 DAYS PRIOR TO ADMISSION. PATIENT ADMITTED TO MEDICAL/SURGICAL TELEMETRY UNIT WHERE CENTRAL TELEMETRY MONITORING INITIATED. PATIENT LEFT THE UNIT FOR AN ECHOCARDIOGRAM WITH TELEMETRY MONITOR IN PLACE AT 1100 . DURING INVESTIGATION OF EVENT, INFORMED THAT ALARM WAS PAUSED BY TELEMETRY TECH WHEN PATIENT LEFT UNIT FOR TEST. PATIENT RETURNED APPROXIMATELY 1 HOUR LATER (12 NOON) ALERT AND ORIENTED X 3. PATIENT WAS SEEN IMMEDIATELY UPON RETURN FROM TEST BY PATIENT CARE TECH WHO ASSISTED HER WITH ADL'S. THE RN ENTERED THE ROOM SHORTLY AFTER AND FINDS THE PATIENT UNRESPONSIVE IN BED. A CODE BLUE WAS CALLED AND RESUSCITATION WAS UNSUCCESSFUL AND PATIENT EXPIRED. TELEMETRY MONITOR WAS ON PATIENT. LAST TRACING FROM CENTRAL TELEMETRY WAS AT 1100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223767 GE TELEMETRY TRANSMITTER MHX GE OAK CREEK APEX-PRO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death