BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALMAX 2100

    MDR report key: 10489 · Received December 14, 1993

    Report

    Report Number
    MW1000107
    Event Type
    Injury
    Date Received
    December 14, 1993
    Date of Event
    December 8, 1993
    Report Date
    December 10, 1993
    Manufacturer
    PACE TECH, INC.
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED INTO PACU FROM OR FOLLOWING GENERAL ANESTHESIA. O2 PLACED ON PT DELIVERY BY MASK. EKG MONITOR, BP CUFF AND SAO2 MONITOR PLACED ON PT. PT STABLE. CONTINUED MONITORING DONE. SAO2 790. V/S TAKEN EVERY 5-15 MIN IN PACU. BETWEEN CYCLES OF V/S RPTR NOTICED THAT THE SAO2 MONITOR CABLE WAS NOT CONNECTED. RPTR WAS STILL RECEIVING A SAT READING OF 95, NO ALARMS AS TO DISCONNECT. THIS IS A GRAVE PROBLEM. THE PT WAS FINE, BUT THIS SYSTEM SHOULD ALARM WHEN THERE IS A BREAK IN THE SYSTEM. PACU PTS ARE FRAGILE AND OFTEN CANNOT SPEAK ECT, SAO2 MONITOR READING ARE A STANDARD OF CARE IN PACU. THIS PROBLEM COULD GIVE A FALSE SENSE OF PT STABILITY. THIS NEEDS TO BE ADDRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALMAX 2100 SAO2 MONITOR, BP HR, EKG MONITOR PACE TECH, INC. 101

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening