BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 2 PS

    MDR report key: 3145250 · Received May 30, 2013

    Report

    Report Number
    3007056120-2013-00008
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Report Date
    February 8, 2013
    Manufacturer
    PHILIPS RESPIRONICS - CHMV
    Product Code
    NPF
    PMA / PMN Number
    K032403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): K032403, K061256. PR#: 1550166. CHMV RECEIVED THE DEVICE FOR EVALUATION AND THE CUSTOMER COMPLAINT ALLEGATION WAS CONFIRMED. THE UNIT WAS FOUND TO ALARM INTERMITTENTLY FOR THE LOSS OF THE ECG SIGNAL. THE MAIN PCA WAS REPLACED TO CORRECT THE RECORDED ISSUE. NO ROOT CAUSE COULD BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THE DEVICE WAS MANUFACTURED IN 2008 AND SOLD IN 2009. NO HISTORY OF THE RECOMMENDED ANNUAL MAINTENANCE IS REFLECTED IN THE DEVICE RECORDED. SMARTMONITOR2 PS AND SMARTMONITOR 2 PSL ARE APNEA MONITORS FOR INFANTS AND VITAL SIGNS MONITORS FOR PEDIATRICS AND ADULTS THAT ARE BOTH DESIGNED TO MONITOR AND RECORD PATIENT'S BREATHING (RESPIRATION), HEART (CARDIAC) ACTIVITY AND, IN THE SMARTMONITOR 2 PS MODEL, SPO2 (OXYGEN SATURATION) LEVELS. THE MONITOR ALERTS YOU IF ANY OF THESE ACTIVITIES EXCEEDS THE LIMITS PRESCRIBED BY THE PHYSICIAN. THE SMARTMONITOR 2 PS DEVICE IS NOT INTENDED TO PREVENT LOSS OF BREATHING OR HEART ACTIVITY. THE SMARTMONITOR 2 PS PARENT'S GUIDE (PN 1031063) STATES: "THE SMARTMONITOR 2 PS IS A MONITORING DEVICE ONLY. IT DOES NOT PREVENT THE LOSS OF BREATHING OR HEART ACTIVITY, NOR WILL IT RESTORE BREATHING OR HEART ACTIVITY. IT WILL NOT PREVENT DEATH. ANYONE USING THE SMARTMONITOR 2 PS SHOULD BE TRAINED IN CURRENT INFANT CARDIOPULMONARY RESUSCITATION (CPR), WHICH IS A PROPER WAY TO RESTORE BREATHING AND HEART ACTIVITY." THE SMARTMONITOR 2 PS PARENT'S GUIDE STATES THE MONITOR'S FUNCTIONAL SELF-TEST CHECKS THAT ALL FEATURES OF THE DEVICE ARE FUNCTIONING PROPERLY. YOU SHOULD PERFORM A FUNCTIONAL SELF-TEST AT LEAST ONCE A WEEK OR ACCORDING TO THE INSTRUCTIONS GIVEN BY YOUR HOME CARE PROVIDER. YOU SHOULD ALSO PERFORM THE TEST: AFTER A LEAD WIRE IS CHANGED; AFTER ONE OF THE PATIENT CABLES IS CHANGED; WHEN THE MONITOR HAS BEEN SCANNED BY AIRPORT X-RAY MACHINES. THE MONITOR'S LIGHTS AND ALARMS SHOULD RESPOND AS JUST DESCRIBED. IF NOT, CONTACT YOUR HOME CARE PROVIDER BEFORE MONITORING YOUR CHILD. DO NOT USE YOUR MONITOR IF THE ALARM SOUNDS WEAK OR DOES NOT ACTIVATE TWICE UPON INITIAL STARTUP. THE USER MANUAL STATES THE FOLLOWING USER/OWNER RESPONSIBILITIES. THE RESPIRONICS MONITOR AND ACCESSORIES ARE DESIGNED TO WORK AS DESCRIBED IN THE OPERATOR'S MANUAL. THE USER(S) OF THIS EQUIPMENT SHOULD NOT USE PARTS THAT HAVE FAILED, EXHIBIT EXCESSIVE WEAR, ARE CONTAMINATED, OR OTHERWISE INEFFECTIVE. THE MONITOR AND ITS ACCESSORIES SHOULD NOT BE MODIFIED. THE FOLLOWING LIST INCORPORATES THE OWNER'S RESPONSIBILITIES: PERIODIC CHECK AND MAINTENANCE OF EQUIPMENT; REPLACEMENT OF COMPONENTS AS REQUIRED FOR SAFE AND RELIABLE OPERATION; REPLACEMENT OF INEFFECTIVE PARTS WITH PARTS SUPPLIED BY RESPIRONICS, INC.; EQUIPMENT THAT IS NOT FUNCTIONING PROPERLY MUST NOT BE USED UNTIL ALL NECESSARY MAINTENANCE HAS BEEN COMPLETED AND A FACTORY AUTHORIZED SERVICE REPRESENTATIVE HAS CERTIFIED THE EQUIPMENT AS READY FOR USE; THE MONITOR AND ANY OF ITS ACCESSORIES SHOULD NOT BE MODIFIED; AS A GENERAL RULE, THE PROPER PERFORMANCE OF THE MONITOR SHOULD BE VERIFIED WITH A RESPIRONICS MODEL 5000 SIMULATOR ACCORDING TO THE CHECKOUT PROCEDURE MANUAL #H580-4000-00 BETWEEN EACH PATIENT USE OR EVERY 6 TO 12 MONTHS OR WHICHEVER IS MORE FREQUENT. THE USER OF THIS EQUIPMENT IS RESPONSIBLE FOR READING, UNDERSTANDING, AND FOLLOWING THE WARNING AND CAUTION STATEMENTS THROUGHOUT THIS MANUAL. ALTHOUGH THE ALARM WAS FOUND TO FUNCTION INTERMITTENTLY, THE FAILURE OF THE DEVICE WAS FOUND DURING THE FUNCTIONAL SELF-TEST CHECKS, WHICH IS THE MITIGATION MEASURE FOR THIS FAILURE. A REVIEW OF THE COMPLAINT DATA BASE SHOWS THAT NO SIGNIFICANT TREND OF THE RECORDED FAILURE HAS BEEN IDENTIFIED. BASED ON A COMPLETE REVIEW OF INFORMATION AVAILABLE AT THIS TIME, QUALITY ASSURANCE HAS DETERMINED THAT THE RECORDED ISSUE HAS BEEN ANTICIPATED IN THE RISK ANALYSIS OR IN THE LABELING AND DOES NOT PRESENT AN INCREASED RISK TO PATIENT SAFETY. THE ISSUE IS CONSIDERED TO BE NON-SYSTEM IC AND NO CORRECTIVE ACTION IS REQUIRED. QUALITY ASSURANCE HAS CONCLUDED THAT NO FURTHER INVESTIGATION ACTIVITY INTO THE ALLEGED EVENT WILL OCCUR. COMPLAINT CODE TRENDING WILL CONTINUE TO BE REVIEWED ON A PERIODIC BASIS.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A REPORT DETAILING A PRODUCT ISSUE ASSOCIATED WITH A SMARTMONITOR 2 PS DEVICE FAILING TO ALARM FOR NO ECG SIGNAL ON (B)(6) 2013. THE DEVICE WAS REPORTEDLY NOT IN PATIENT USE AND THERE IS NO ALLEGATION OF HARM ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240434 SMART MONITOR 2 PS APNEA MONITOR NPF PHILIPS RESPIRONICS - CHMV 1014557

    Patients

    Seq Age Sex Outcome Treatment
    1