BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAM 451N

    MDR report key: 915767 · Received March 14, 2007

    Report

    Report Number
    2124823-2007-00023
    Event Type
    Malfunction
    Date Received
    March 14, 2007
    Report Date
    March 14, 2007
    Manufacturer
    GE HEALTHCARE
    Product Code
    DRT
    PMA / PMN Number
    k011000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PART RETURNED TO GE FOR INVESTIGATION AND IT WAS DETERMINED THAT THE CARE UNIT IS UTILIZING WRONG SPO2 INTERCONNECT CABLE P/N 407252-002 WITH TRAM 451N MODULES. SPO2 INTERCONNECT CABLE P/N 407252-002 IS INCOMPATIBLE WITH THE TRAM 45IN MODULES AND MAY RESULT IN INCORRECT SPO2 VALUES. THE P/N 407252-002 CABLE CONNECTOR IS KEYED AND THIS KEY DOES NOT MATCH THE KEYING ON THE 451N OXISMART TRAM MODULE. IN ORDER TO CONNECT THE CABLE TO THE MONITOR, THE KEY WOULD NEED TO BE DEFEATED (I.E. BROKEN). GE HEALTHCARE CONFIRMED THAT BOTH NEONATAL ICU AND HOSPITAL HAVE BEEN PURGED OF INCOMPATIBLE SPO2 INTERCONNECT CABLE P/N 407252-002. CABLES HAVE BEEN REPLACED WITH COMPATIBLE 2006644-001 NELLCOR SPO2 INTERCONNECT CABLE. SPO2 TRAM MODULE AND CABLE COMPATIBILITY IS ADEQUATELY DESCRIBED IN LABELING VIA THE SOLAR 8000M PT MONITOR OPERATOR'S MANUAL, VERSION 4, 2000701-107 CHAPTER 14, "SPO2": SECTION "INTRODUCTION", SUBSECTION, "MODULE AND PROBE COMPATIBILITY", "WARNING", "TRAM 451N AND TRAM 851N MODULES REQUIRE NELLCOR OXISMART XL CABLES AND PROBES. OLDER (NON-OXISMART XL) CABLES MUST NOT BE PLUGGED INTO THE SPO2 CONNECTOR ON THESE MODULES. USE OF NON-OXISMART XL CABLES MAY RESULT IN ERRONEOUS READINGS." AND "NOTE"; THE SPO2 CABLE SHOULD PLUG INTO THE MODULE'S SPO2 CONECTOR EASILY AND SECURELY. DO NOT USE EXCESSIVE FORCE TO CONNECT THE CABLE. IF THE SPO2 CABLE DOES NOT EASILY FIT INTO THE SPO2 CONNECTOR ON THE MODULE, IT IS LIKELY THAT YOU DO NOT HAVE THE APPROPRIATE CABLE FOR THAT MODULE."

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT MONITOR READING SPO2 VALUES HIGHER THAN EXPECTED. STAFF HAS ONLY NOTICED THIS WHEN SIGNIFICANT DESAT HAS OCCURRED. BIOMED HAS TESTED THE MONITOR USING A SIMULATOR AND CANNOT REPRODUCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAM 451N PHYSIOLOGIC PT MONITOR DRT GE HEALTHCARE TRAM 451N *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR