BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMETRIX Y SENSOR

    MDR report key: 312872 · Received January 8, 2001

    Report

    Report Number
    MW1020840
    Event Type
    Other
    Date Received
    January 8, 2001
    Date of Event
    March 1, 2000
    Report Date
    January 5, 2001
    Manufacturer
    NOVAMETRIX MEDICAL SYSTEMS, INC.
    Product Code
    DQA
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 4/20/01: 1. THE MODEL NUMBER AND/OR CATALOG NUMBER OF THE DEVICE LISTED IN THE MEDICAL DEVICE REPORT. NOVAMETRIX HAS NOT RECEIVED ANY DEVICE SPECIFIC REPORT. PLEASE SEE THE INFO BELOW FOR AN EXPLANATION CONCERNING THE USER FACILITY. 2. THE MFG LOT AND/OR SERIAL NUMBER OF THE DEVICE LISTED IN THE MEDICAL DEVICE REPORT. NOVAMETRIX HAS NOT RECEIVED ANY DEVICE SPECIFIC REPORTS. PLEASE SEE THE INFO BELOW FOR AN EXPLANATION CONCERNING THE USER FACILITY. 3. THE FINAL RESULTS OF ANY FAILURE ANALYSIS OR LAB TESTING OF THE DEVICE LISTED IN THE REPORT(S) INCLUDING: (1) A COMPLETE DESCRIPTION OF THE METHODOLOGY (IES) USED, (2) AN IDENTIFICATION OF THE FAILURE MODE (S) AND/OR MECHANISM (S) AND THE ASSOCIATED COMPONENT (S) INVOLVED, (3) ANY CONCLUSIONS BASED ON THE FINAL FAILURE ANALYSIS OR LAB TEST RESULTS. NOVAMETRIX INSTALLED ITS PULSE OXIMETERS (10*MODEL 515B WITH Y SENSORS AND 5*MODEL 520A WITH FINGER SENSORS) IN PLACE OF THE EXISTING OXIMETERS PREVIOUSLY USED AT THE FACILITY. THE HOSP STAFF WAS INSTRUCTED ON THE USE AND PLACEMENT OF CO'S PULSE OXIMETER SENSORS DURING VARIOUS "IN-SERVICE" SESSIONS. WHILE MFR'S CLINICAL STAFF WAS IN ATTENDANCE MFR HAD EXPERIENCED NO PROBLEMS RELATIVE TO SENSOR PLACEMENT INCLUDING THE APPLICATION OF THE SENSORS USING NOVAMETRIX TAPING SYSTEMS TO ENSURE THERE WAS NOT EXCESSIVE PRESSURE BY WRAPPING THE APPLICATORS TOO TIGHT ON THE PTS. THE PREDECESSOR SYSTEM USED DISPOSABLE BANDAGE (TAPE) STYLE SENSORS IN CONTRAST TO MFR'S REUSABLE STYLE SENSORS USED IN CONJUNCTION WITH TAPES OR FOAM WRAP APPLICATORS. WHEN MFR WAS NOT IN ATTENDANCE, MFR RECEIVED REPORTS OF BLISTERS WHICH DETERMINED (AND COMMUNICATED) WAS CAUSED BY EXCESSIVE APPLICATOR PRESSURE, INFREQUENT SITE CHANGES AND NOT HEAT. THEREFORE MFR BELIEVES THE REPORT OF PROBLEMS WERE DUE TO USER DIFFICULTY WITH SENSOR TAPING APPLICATIONS AND/OR ADHERENCE TO MFR'S RECOMMENDATIONS FOR APPLICATION, SITE CHECKING AND ATTENTION TO SPECIFIC PT REQUIREMENTS. THERE WERE NO UNTIS REMOVED FROM SERVICE AT HOSP AND RETURNED TO NOVAMETRIX FOR EVALUATION. PLEASE SEE BELOW FOR MORE DETAILED INFO. 4. ANY EVALUATION OF OTHER INFO USED BY FIRM TO DETERMINE WHETHER THE EVENTS DESCRIBED IN THE MEDICAL DEVICE REPORT ARE OR ARE NOT ATTRIBUTABLE TO THE DEVICE. THE REPORT AS DESCRIBED BY THE USER FACILITY IS DUE TO USER ERROR DURING SENSOR APPLICATION AND NOT ATRRIBUTABLE TO MFR'S DEVICE. 5. A COPY OF ALL CURRENT LABELING FOR THE DEVICE, INCLUDING DIRECTIONS FOR USE, CAUTION STATEMENTS, TECHNICAL MANUALS AND PRODUCT PERFORMANCE REPORTS. THE USER MANUAL AND SENSOR LABELING IN ADDITION TO SAMPLE EDUCATIONAL INFO USED AT THE REPORTING FACILITY ARE ATTACHED. 6. THE DATE THE EVENT DESCRIBED IN THE MEDICAL DEVICE REPORT OCCURRED. THERE WERE NO FORMAL INCIDENT REPORTS IDENTIFIED OR SUBMITTED. THE INFO IS BASED UPON HOSP EXPERIENCE DESPITE MFR'S REPEATED ATTENTION WITH ON SITE CLINICAL ASSISTANCE. 7. THE DATE FIRM RECEIVED INFO ABOUT THE EVENT DESCRIBED IN THE MEDICAL DEVICE REPORT. MFR HAD AN ONGOING DIALOGUE WITH THE FACILITY STAFF AND ITS CLINICAL STAFF. 8. THE NUMBER OF PERSONS WHO DIED AND/OR THE NUMBER OF PERSONS WHO WERE INJURED AS A RESULT OF THE EVENT IN THE MEDICAL DEVICE REPORT. THERE WERE NO SIGNIFICANT INJURIES OR DEATHS ASSOCIATED WITH THIS REPORT. 9. THE CURRENT STATUS OF THE DEVICE, INCLUDING WHETHER THE DEVICE IS BEING, OR HAS BEEN, RETURNED TO THE FIRM/FACILITY. IF THE DEVICE IS NOT RETURNED, INDICATE THE DISPOSITION OF THE DEVICE, EG, THE DEVICE WAS DISPOSED OF, REMAINS IMPLANTED, ETC. ALL DEVICES ARE STILL IN USE AT THE FACILITY. IN RESPONSE TO THE SITUATION LEADING TO THE USER FACILITY REPORT, MFR INCLUDES THE FOLLOWING INFO CONCERNING ITS EXPERIENCE WITH THIS INSTALLATION AND INTERACTION WITH THE FACILITY STAFF. NOVAMETRIX MEDICAL SYSTEMS INC, SHIPPED 20 PULSE OXIMETERS TO HOSP ON 4/30/00. THESE DEVICES SHIPPED INCLUDED 15 EACH MODEL 515B UNITS WITH Y SENSORS AND 5 EACH MODEL 520A UNITS WITH FINGER SENSORS. NOVAMETRIX CLINICAL SUPPORT HAS VISITED THIS HOSP TO ADDRESS AND CORRECT THE ISSUES CONVEYED TO IT BY THE DIR OF CARDIOPULMONARY SERVICES. THE INITIAL VISIT WAS 6/8/00. AT THIS VISIT, MFR CONDUCTED THE FOLLOWING INTERVENTIONS. TRAINED CLINICAL STAFF ON APPROPRIATE SENSOR APPLICATION AND TECHNIQUE. IN-SERVICE TRAINING ON USE OF MONIOR. REINFORCEMENT OF NOVAMETRIX POLICY ON SITE CHECKS. IN-SERVICE WAS CONDUCTED FOR THE CARDIO-PULMONARY DEPT AND NURSING STAFF. AT THIS VISIT THE PROBE APPLICATION WAS BEING TASKED TO THE CNA STAFF OF THIS FACILITY. POSTERS DEPICTING APPROPRIATE SITE AND APPLICATOR USE WERE SENT TO BE DISPLAYED ON THE NURSING UNITS (ATTACHMENT INCLUDED). IN SUMMARY, IT IS FELT THAT THESE PROBLEMS ARE CONTRIBUTED TO THE SPECIFIC USER FACILITY PRACTICES AND NOT AS A RESULT OF MFR'S DEVICES. NOVAMETRIX HAS BEEN DISTRIBUTING PULSE OXIMETER MONITORS SINCE 1985 (>50,000 UNITS) AND IT RARELY RECEIVES REPORTS OF PRESSURE/BURN BLISTERS. AS YOU HAVE SEEN (ABOVE). MFR'S PRODUCT LABELING IS EXPLICIT IN THE DETAIL FOR SENSOR APPLICATION AND MFR FEELS THAT THE USER FACILITY HAS NOT EMBRACED THIS INFO AND ITS ON-SITE CLINICAL EDUCATION EFFORTS IN THEIR PRACTICE.

    Description of Event or Problem · 1

    BETWEEN 1/00 - 1/01, SIXTEEN PEDIATRIC PTS USING CONTINUOUS PULSE OXIMETER MONITORS RECEIVED 17 INJURIES FROM THE LED SENSORS. INJURIES RANGED FROM REDNESS LASTING MORE THAN 12 HRS TO BLISTERS. SOME MINIMAL SCARRING OCCURRED. INJURIES WERE NOT FROM THE MONITOR ITSELF, BUT THE SENSOR PROBE SECURED BY A SOFT STRAP ON A DIGIT OR FOOT. CONSULTED WITH MFR TWICE IN 2000 WHO PROVIDED INSERVICE AND WRITTEN INSTRUCTIONS/POSTERS ON PROPER PROBE PLACEMENT. DURING 3-WEEK INTENSIVE STUDY, AN ADD'L 8 INJURIES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784 NOVAMETRIX Y SENSOR PULSE OXIMETER MONITOR DQA NOVAMETRIX MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other