BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR

    MDR report key: 3063561 · Received April 12, 2013

    Report

    Report Number
    3007056120-2013-00005
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Report Date
    April 9, 2013
    Manufacturer
    CHILDRENS MEDICAL VENTURES LLC
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING THE INVESTIGATION, THE UNIT WAS VISUALLY INSPECTED AND FOUND TO HAVE MULTIPLE SIGNS OF PHYSICAL DAMAGE ASSOCIATED WITH BEING DROPPED. THE PERFORMANCE VERIFICATION CHECKOUT PROCEDURE TEST FOUND NO ISSUES WITH THE MAIN PCA. THE DESIGN INCORPORATED VISUAL ALARM INDICATORS WERE FOUND TO WORK TO SPEC TO ALERT A CAREGIVER OF A POTENTIAL EVENT. HOWEVER, THE SONALERT ALARM MODULE WAS FOUND TO BE INOPERABLE DUE TO EXTENSIVE PHYSICAL DAMAGE. ADDITIONALLY, THE UNITS' BATTERY ENCLOSURE WAS FOUND TO BE DAMAGED AND THE BATTERY WAS FOUND TO BE COMPLETELY DISCHARGED RENDERING THE UNIT INOPERABLE. THE UNIT COULD NOT BE PLACED INTO SERVICE IN ITS CURRENT CONDITION. SMARTMONITOR 2 IS DESIGNED TO MONITOR AND RECORD PT'S BREATHING (RESPIRATION), HEART (CARDIAC) ACTIVITY. THE MONITOR ALERTS YOU IF ANY OF THESE ACTIVITIES EXCEEDS THE LIMITS PRESCRIBED BY THE PHYSICIAN. PT ALARM LIMITS ARE SET BY THE HEALTH CARE PROFESSIONAL BEFORE THE SMARTMONITOR2 IS DELIVERED TO THE PT. DURING MONITORING, WHEN THE PT'S BREATHING EFFORT AND OR HEART ACTIVITY ARE NOT WITHIN THESE SET BOUNDARIES, AN INDICATOR LIGHT COMES ON AND AN ALARM SOUNDS. 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 IT ACCESSORIES SHOULD NOT BE MODIFIED. THE FOLLOWING LIST INCORPORATE 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 REP 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 CHECK OUT PROCEDURE MANUAL #H580-4000-00 BETWEEN EACH PT 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. BASED ON A COMPLETE REVIEW OF THIS COMPLAINT, IT IS CONCLUDED THAT THE FAILURE OF THE DEVICE IS AN ISOLATED NON SYSTEMIC ISSUE ASSOCIATED WITH EXCESSIVE PHYSICAL DAMAGE. THE UNIT WOULD NOT PASS THE PERFORMANCE VERIFICATION CHECKOUT PROCEDURE TEST TO BE PUT INTO PT USE WHICH IS THE MITIGATION FOR THIS FAILURE MODE AND IS REQUIRED BETWEEN EACH PT USE OR EVERY 6 TO 12 MONTHS OR WHICHEVER IS MORE FREQUENT. QA HAS DETERMINED THAT NO FURTHER INVESTIGATION INTO THE ALLEGED COMPLAINT ISSUE IS APPROPRIATE AT THIS TIME.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A CUSTOMER COMPLAINT ALLEGING A PRODUCT ISSUE OF "CIRCUIT BOARD DEFECTIVE, RETIRED." THERE IS NO ALLEGATION OF PT HARM AND THE DEVICE WAS NOT IN USE AT THE TIME OF THE REPORTED COMPLAINT ISSUE. DURING THE REPAIR EVAL, THE UNIT WAS FOUND TO HAVE AN ALARM FAILURE. THE UNIT WAS FORWARDED TO THE CHMV PRODUCT INVESTIGATION LAB FOR A FORMAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157853 SMART MONITOR APNEA MONITOR FLS CHILDRENS MEDICAL VENTURES LLC U4003

    Patients

    Seq Age Sex Outcome Treatment
    1