BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDICAL RESEARCH LAB. INC.

    MDR report key: 266524 · Received February 16, 2000

    Report

    Report Number
    266524
    Event Type
    Death
    Date Received
    February 16, 2000
    Date of Event
    January 26, 2000
    Report Date
    February 10, 2000
    Manufacturer
    MEDICAL RESEARCH LABS, INC.
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    VERBATIM FROM INCIDENT CASE REPORT FILED BY PARAMEDIC CREW: "UPON ATTEMPT TO USE THE CARDIAC MONITOR AT THE SCENE THE MONITOR DIDN'T WORK. AFTER CHANGING SEVERAL BATTERIES TO GET IT TO WORK NOTHING HELPED ONLY A SMALL DOT ON THE SCREEN. PARAMEDIC CALLED EFA (OFFICE OF EMERG. COMM) TO REQUEST A CO FOR ASSISTANCE WITH THE EQUIPMENT. (ALS) ENGINE CO ARRIVED AND PARAMEDIC USED THEIR MONITOR AND COMPLETED THE CALL. SUPERVISOR NOTIFIED."

    Description of Event or Problem · 1

    BACKGROUND AND OBSERVATIONS: ON RECEIPT OF THE EQUIPMENT AND ACCESSORIES INVOLVED IN AMBULANCE CO EVENT, A SUPPORT AND LOGISTICS DIVISION REP VISULALLY INSPECTED THE EXTERIOR OF ALL OF THE EQUIPMENT AND ITS ASSOCIATED COMPONENTS, AS IT IS ROUTINELY PERFORMED ON ALL INCOMING EQUIPMENT IDENTIFIED AS BEING OUT-OF-SVC BY FIELD PERSONNEL, BEFORE TURNING IT OVER TO THE CONTRACTED MAINTENANCE VENDOR'S REP (TECH). NO EVIDENCE OF PHYSICAL DAMAGE OR CONTAMINATION OF ANY KIND WAS NOTED, TO INCLUDE ANY EVIDENCE OF SOLID OR LIQUID MATTER, NEW OR OLD, ANYWHERE ON THE SURFACE OF THE DEVICE. ALTHOUGH AN SLD REP IS NORMALLY PRESENT WHEN THE DEVICE IS FIRST TESTED FOR FUNCTIONALITY BY THE CONTRACTED TECH, AN OPPORTUNITY TO DO SO IN THIS CASE WAS NOT PROVIDED BY THE VENDOR BEFORE THE DEVICE WAS DISASSEMBLED COMPLETELY. NO EVIDENCE OF ANY NORMAL FUNCTIONALITY WHATSOEVER, WAS EVER DEMONSTRATED TO SLD BY THE VENDOR, WITH WHICH TO CONTRADICT THE REPORT SUBMITTED BY THE PARAMEDICS. ON VISUAL INSPECTION OF THE INTERNAL COMPONENTS, LARGE QUANTITIES OF A WHITE/BLUE-POWDERY CAUSTIC-LIKE "OXIDATION RESIDUE" WAS NOTICED AROUND THE SOLDERED CONNECTIONS IN 2 SEPARATE AND APART ELECTRONIC BOARDS. THE DRIED, WHITE "GHOSTLY" REMAINS OF WHAT MAY HAVE BEEN CONDENSATION FROM AMBIENT MOISTURE COULD BE SEEN IN THE IMMEDIATE AREAS SURROUNDING ONE OF THE 2 COMPONENTS. NO ACUTAL MOISTURE ("WET") OR EVIDENCE OF RECENT MOISTURE ("DAMP") OR OF SUDDEN ELECTRICAL ARCHING, BURNING, MELTING OR OTHER SUCH "ELECTRICAL SHORTAGE" TALE-TELL SIGNS, LIKELY TO HAVE BEEN CAUSED BY A SUDDEN FLUID "SPILL" WERE NOTED. ALTHOUGH NO MRL SVD TAG WAS NOTED, INDICATING THE LAST DATE THE DEVICE WAS FORMALLY INSPECTED OR SERVICED BY AN MRL TECH, THE DEVICE WAS AMONGST THE UNITS WHICH HAD BEEN INSPECTED AND "CONVERTED" BY MRL DURING THE LATE OCTOBER, NOVEMBER AND EARLY DECEMBER 1998 "RETRO-FIT" ACTIVITY, CONDUCTED AT SLD. ON VISUAL INSPECTION, THE MAIN ELECTRICAL BOARD CLEARLY SHOWED THAT IT HAD INDEED BEEN SUBJECTED TO THE "APPLICATION OF CAULKING", WHICH WAS A DISTINGUISHING ALTERATION PERFORMED BY THE MRL TECHS DURING THIS RETROFIT PERIOD. THIS WOULD INDICATE THAT THE UNIT WOULD HAVE BEEN LAST INTERNALLY INSPECTED BY MRL, NO MOR THAN 14 AND NO LESS THAN 12 MONTHS PREVIOUSLY. COMPARATIVE ANALYSIS: THE IMPLICATIONS THAT CAN BE DERIVED FROM THE WRITTEN STATEMENTS SUBMITTED BY THE MRL TECH IN HIS REPORT, SUGGEST THAT THE EVENT CAN BE POSITIVELY ATTRIBUTED TO A SINGLE ACT, SUDDENLY AND RECENTLY COMMITTED BY A "USER" OF THE DEVICE AND IT IMPLIES FAULT AT THE OPERATOR LEVEL, FROM WHICH THE READER COULD INFER EITHER MALICE, CARELESSNESS OR NEGLIGENCE ON THE PART OF THE DEPT'S PERSONNEL. IT MAY BE NOTEWORTHY TO RECOGNIZE THAT THE TECH USED BY MRL TO INSPECT AND GENERATE THE MDR REPORT WAS NOT THE CUSTOMARY TECH EMPLOYED BY THE VENDOR FOR THE WEEKLY PREVENTATIVE MAINTENANCE AND REPAIR SVS CONDUCTED AT SLD, BUT RATHER THE VENDOR'S SENIOR TECH REP (NATIONAL SVC MGR) AND A KNOWN MEMBER OF THE MRL MGMT TEAM. ON THE OTHER HAND, SLD'S ASSEMSSMENT OF THE EVIDENCE SUGGESTS THAT THE FAILURE MAY HAVE BEEN CAUSED BY: A PROTRACTED DETERIORATION OF THE ELECTRICAL CONDUCTIVITY REQUIRED TO OPERATE THE DEVICE, AS EVIDENCED BY THE ACCUMULATION OF CORROSIVE DEPOSITS, OCCURRING OVER AN EXTENDED PERIOD OF TIME, WHICH MAY OR MAY NOT HAVE BEEN SOLELY CAUSED BY EXPOSURE TO MOISTURE OR HUMIDITY WHICH SOURCE IS UNDETERMINED. SUCH A SOURCE OF HUMIDITY, IF ANY, COULD INCLUDE SIMPLE CONDENSATION BROUGHT ABOUT BY THE ENVIRONMENTAL CHANGES TO WHICH THE DEVICE IS NORMALLY EXPOSED TO, SUCH AS GOING FROM AN AMBIENT ENVIRONMENT OF HIGH RELATIVE HUMIDITY OUTDOORS, DURING WARM SUMMER MONTHS AND SUDDENLY ENTERING A LOW TO NONEXISTENT RELATIVE HUMIDITY ENVIRONMENT, CAUSED BY INDOOR AIR-CONDITIONING, ETC, AMONG OTHERS. THE 360SLX IS NOT A SEALED UNIT, IMPERVIOUS TO HUMIDITY AND AS SUCH, THE ABOVE EXPLANTATION IS MORE THAN JUST POSSIBLE, BUT BASED ON THE PHYSICAL EVIDENCE, MORE THAN LIKELY. THE NOTED OBSERVATIONS OF "EVIDENCE OF SPILLS" EXPRESSED BY THE MRL TECH, WHERE NONE CAN BE FOUND AND THE FAILURE TO DEMONSTRATE TO ANY MEMBER OF THE SLD STAFF THAT "THE EQUIPMENT FUNCTIONS PROPERLY, DURING A COMPLETE PERFORMANCE TEST", ALTHOUGH IT IS THEN IMMEDIATELY FOLLOWED BY A RAPID AND TOTAL DISASSEMBLY, FOR WHICH NO IMMEDIATE REASON WOULD HAVE EXISTED (IF RPTR IS TO ACCEPT THE CLAIMS OF A PRIOR SUCCESSFUL FUNCTIONALITY TEST), CASTS SOME DOUBT ON THE VERACITY AND/OR ACCURACY OF THE TECH'S FINDINGS. IN ADDITION, THE IMPLICIT PLACEMENT OF BLAME ON THE DEPT'S PERSONNEL, BASED ON UNCORROBORATED FINDINGS, COULD BE REASONABLY INTERPRETED AS AN ATTEMPT BY THE MGR-TECH TO EVADE ANY POTENTIAL ASSESSMENT OF OEM CULPABILITY DURING A LATTER EXAMINATION OF THE DOCUMENTS BY EITHER A REGULATORY AGENCY OR A LITIGATING PLAINTIFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL RESEARCH LAB. INC. 360SLX ECG MONITOR/DEFIB. LDD MEDICAL RESEARCH LABS, INC. 360SLX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death