BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAM 451M

    MDR report key: 4609980 · Received March 17, 2015

    Report

    Report Number
    2124823-2015-00005
    Event Type
    Injury
    Date Received
    March 17, 2015
    Date of Event
    December 31, 2014
    Report Date
    February 16, 2015
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K053121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGAITON IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS LIMITED TO THE INFORMATION PROVIDED BY THE CUSTOMER. THE TRAM 451M MODULE WAS NOT RETURNED FOR INVESTIGATION, HOWEVER THE TRAM 451M WAS TESTED BY THE CUSTOMER AFTER THE REPORTED INCIDENT AND THE PROBLEM WITH LOW SPO2 SATURATION VALUES COULD NOT BE DUPLICATED. THE TRAM 451M INCORPORATES MASIMO SET OEM SPO2 TECHNOLOGY. THE SPO2 BOARD IN THE TRAM 451M IS SUPPLIED BY MASIMO CORPORATION. THE INITIAL PATIENT ABG CAME BACK LOW WHICH WAS CONSISTENT WITH THE LOW SPO2 SATURATION VALUE (70% - 80% RANGE) DISPLAYED ON THE MONITOR. IN ADDITION, THE PATIENT HAD A VERY WEAK PULSE WHICH IS SUGGESTIVE OF LOW PERFUSION AND IN CONJUNCTION WITH THE RECENT ACTIVITY (THE PATIENT WAS TURNED) MAY HAVE CONTRIBUTED TO A TRANSIENT LOW SPO2 WHICH WAS ALSO REFLECTED IN THAT INITIAL ABG. ALTHOUGH THE FOLLOW-UP ABG WAS NORMAL, SPO2 READINGS MAY VARY FROM ABG VALUES DUE TO MEDICAL CONDITIONS SUCH AS REYNAUD'S DISEASE, POOR PERIPHERAL VASCULATURE, HYPOPERFUSION SECONDARY TO COLD EXTREMITIES OR VASOCONSTRICTION FROM CERTAIN MEDICATIONS (E.G. VASOPRESSORS). IN ADDITION INCORRECT PROBE PLACEMENT OR AMBIENT LIGHT INTERFERENCE CAN AFFECT SPO2 READINGS. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION WITH REGARDS TO TREATMENT PROVIDED, WITH NO RESPONSE. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF DEVICE MALFUNCTION. BASED ON THE INFORMATION AVAILABLE THE LIKELY ROOT CAUSE IS RELATED TO A COMBINATION OF CHANGING PATIENT MEDICAL CONDITIONS AND SPO2 PROBE PLACEMENT. THERE IS NO INDICATION OF DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    PER THE USER FACILITY REPORT: "FINISHED CLEANING AND TURNING PATIENT WHEN NOTICED 02 SATURATION DROPPED TO THE 70'S-80'S. CHANGED LOCATION OF O2 SAT PROBE AND ALSO CHANGED THE O2 SAT CABLE. MONITOR CONTINUED TO READ O2 SAT OF 70-80%. PATIENT HAD VERY WEAK PULSES AND AS A RESULT HAD SEVERAL ATTEMPTS FOR AN ABG. ABG RECEIVED AND PAO2 SATURATION WAS LOW. QUESTIONABLE WHETHER IT WAS A TRUE ABG OR FROM A VENOUS SITE. DECIDED TO PLACE AN ARTERIAL LINE. ARTERIAL LINE WAS PLACED AFTER SEVERAL ATTEMPTS. SECOND ABG DRAWN AFTER ARTERIAL LINE. PAO2 WITHIN NORMAL RANGE. PATIENT ALSO RECEIVED A BRONCHOSCOPY. DURING THIS TIME A PORTABLE O2 SATURATION MONITOR RECEIVED FROM OR AND NOTICED DISCREPANCY FROM PORTABLE SATURATION MONITOR TO THE MONITOR IN THE ROOM. PORTABLE SATURATION MONITOR READ 99% WHILE THE MONITOR IN THE ROOM READ 80%. DECIDED TO CHANGE OUT THE TRAM IN THE MONITOR AND THE NEW TRAM CORRELATED WITH THE READINGS FROM THE PORTABLE SATURATION MONITOR." NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180710 TRAM 451M PHYSIOLOGICAL PATIENT MONITOR MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other