BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUETTE SOLAR 8000

    MDR report key: 144354 · Received January 12, 1998

    Report

    Report Number
    MW4002102
    Event Type
    Injury
    Date Received
    January 12, 1998
    Date of Event
    December 10, 1997
    Report Date
    December 24, 1997
    Manufacturer
    MARQUETTE MED. SYS.
    Product Code
    MHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN 88 YR OLD MALE WAS ADMITTED ON 10 DECEMBER 1997 AND PLACED ON A MARQUETTE MODEL SOLAR 8000 MONITOR FOR CONTINUOUS CARDIAC MONITORING, CONTINUOUS PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE MONITORING. ON 11 DECEMBER 1997 APPROX 1430 HRS, THE ICU NURSE OBSERVED PT WITH INCREASED RESPIRATION RATE, FINGERNAIL BEDS AND EARS BLUISH IN COLOR. MARQUETTE PULSE OXIMETER, USING AN OHMEDA EAR PROBE, SHOWED READING OF 99-100%. ARTERIAL BLOOD WAS DRAWN FOR BLOOD GAS ANALYSIS BY MED LAB. THE SATURATED ARTERIAL OXYGEN (SAO2) WAS ALSO CHECKED WITH A PROPAQ MONITOR USING A NELLCOR FINGER PROBE AND THE PT SAO2 READING WAS 62%. THE LAB BLOOD GAS REPORT CONFIRMED SAO2 READING OF 62%. THE ATTENDING PHYSICIAN WAS ALERTED AND THE PT WAS PLACED ON 98% FACE TENT AND THE O2 SATURATION READINGS BEGAN TO IMPROVE. TWO DIFFERENT OHMEDA PULSE OXIMETER PROBES WERE TESTED AND FOUND TO READ 100% SAO2. MARQUETTE MEDICAL REP WAS IN FACILITY DURING THIS OCCURRENCE AND HAS GREAT KNOWLEDGE CONCERNING THIS . REP SAID HE WOULD PASS HIS INFO TO MARQUETTE MED, ON MONDAY 15 DECEMBER 97 AND THAT THEY WOULD CONTACT UF WHEN THE REASON FOR THE INCORRECT READINGS WERE KNOWN. NOTE: ALL OHMEDA EAR PROBES HAVE BEEN COLLECTED AND ARE SECURED TO PREVENT USE OF EAR PROBES ON MARQUETTE MODEL 8000 MONITORS. ORDERS HAVE ALSO BEEN ISSUED NOT TO USE OHMEDA EAR PROBES. 7146 OHMEDA EAR PROBES READ INCORRECT VALUES WHEN USED WITH THE TRAM 400 SL. MARQUETTE MED SYS AND OHMEDA INC MED SYS DIV ARE WORKING THIS PROBLEM. NO CLOSURE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUETTE SOLAR 8000 MULTI-PARAMETER MODULE MHX MARQUETTE MED. SYS. TRAM 400SL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR 1. OHMEDA O2 SAT PROBE| 2. NELLCOR O2 SAT PROBE