BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 2 PS

    MDR report key: 3382845 · Received September 4, 2013

    Report

    Report Number
    3007056120-2013-00014
    Event Type
    Malfunction
    Date Received
    September 4, 2013
    Report Date
    August 5, 2013
    Manufacturer
    PHILIPS RESPIRONICS - CHMV
    Product Code
    NPF
    PMA / PMN Number
    K032403
    Removal / Correction Number
    NO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): K061256. (B)(4). THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER WAS NOT ABLE TO BE CONFIRMED BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. THE PURPOSE OF THE SMARTMONITOR 2 FUNCTIONAL SELF-TEST IS TO CHECK THAT ALL THE FEATURES OF THE UNIT ARE FUNCTIONING PROPERLY. A FUNCTIONAL SELF-TEST SHOULD BE PERFORMED AT LEAST ONCE A WEEK OR ACCORDING TO THE INSTRUCTIONS GIVEN BY THE HEALTH CARE PROFESSIONAL. YOU SHOULD ALSO PERFORM THE TEST: AFTER A LEAD WIRE IS CHANGED; AFTER THE PT CABLE IS CHANGED. 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 THE 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 SMARTMONITOR2 PS AND SMARTMONITOR2 PSL ARE INTENDED FOR USE IN THE CONTINUOUS MONITORING OF RESPIRATION, HEART RATE, AND SPO2 LEVELS (SMARTMONITOR2 PS ONLY) OF INFANT, PEDIATRIC, AND ADULT PTS. THE DEVICE DETECTS AND ALARMS FOR PERIODS OF HIGH OR LOW HEART RATE, HIGH OR LOW BREATH RATE, AND HIGH OR LOW SATURATION (SMARTMONITOR2 PS ONLY). WHEN USED AS AN INFANT MONITOR, IT IS INTENDED FOR USE IN A HOME HOSPITAL ENVIRONMENT. FOR INFANTS ONLY, IT MONITORS AND ALARMS FOR CENTRAL APNEAS. WHEN USED AS A PEDIATRIC OR ADULT MONITOR, IT IS INTENDED FOR USE IN A HOSPITAL ENVIRONMENT. PT ALARM LIMITS ARE SET BY THE HEALTH CARE PROFESSIONAL BEFORE THE SMARTMONITOR2 PS IS DELIVERED TO THE PT AND ARE TYPICALLY SET UP THE PRESCRIBED SETTINGS WHICH INCLUDE A DELAY BEFORE RECORDING APNEAS AND A DELAY BEFORE ANNUNCIATING AN ALARM FOR AN APNEA CONDITION. BASED ON A COMPLETE REVIEW OF THE COMPLAINT ALLEGATION, CHMV HAS NO REASON TO BELIEVE THE DEVICE IN QUESTION DID NOT PERFORM TO SPECIFICATION; EFFECTIVELY NOTIFYING THE CAREGIVER OF A POTENTIAL EVENT. IT IS DETERMINED THAT NO FURTHER INVESTIGATION INTO THE ALLEGED COMPLAINT ISSUE IS APPROPRIATE AT THIS TIME. HOWEVER, IF THE DEVICE IS RETURNED FOR INVESTIGATION AND IT IS CONCLUDED THAT A MALFUNCTION OUTSIDE OF THE DESIGN SPECIFICATIONS TOOK PLACE, A F/U ADDITIONAL INFO REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A REPORT FROM A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER STATING THAT A SMART MONITOR INFANT APNEA MONITOR HAD FAILED THE SELF-TEST. NO RESULTING EFFECT ON A PT OR POTENTIAL USER HAS BEEN REPORTED. THE DEVICE WAS REPORTEDLY NOT IN USE AT THE TIME OF THE REPORTED EVENT. HOWEVER, IT IS NOT KNOWN IF THE DEVICE ALARMED APPROPRIATELY DURING THE SELF-TEST PROCESS. THE DME HAS BEEN CONTACTED FOR ADDITIONAL INFO AND STATED THAT THEY WERE NOT AWARE OF A COMPLAINT ALLEGATION ASSOCIATED WITH THE DEVICE. ADDITIONALLY, THE DME STATED THAT THE DEVICE'S LOCATION WAS NOT CURRENTLY KNOWN BUT THAT IT WAS NOT CURRENTLY WITH A PT. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE ALLEGED FAILURE IS BEING REPORTED DUE TO THE FACT THAT IT IS UNK WHETHER OR NOT THE UNIT ALARMED APPROPRIATELY FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438892 SMART MONITOR 2 PS NPF PHILIPS RESPIRONICS - CHMV 1014557

    Patients

    Seq Age Sex Outcome Treatment
    1