BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-SERIES HEATED HUMIDIFIER

    MDR report key: 1476302 · Received June 18, 2009

    Report

    Report Number
    2518422-2009-00028
    Event Type
    Malfunction
    Date Received
    June 18, 2009
    Date of Event
    May 1, 2009
    Report Date
    May 19, 2009
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K052110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORICAL REVIEW OF AFFECTED COMPLAINT RECORDS.

    Description of Event or Problem · 1

    DURING THE SERVICING OF A HEATED HUMIDIFIER AT THE MANUFACTURER'S SERVICE CENTER, THERMAL DAMAGE TO THE DEVICE'S HOUSING WAS OBSERVED. NO REPORT OF PATIENT OR USER INJURY OR HARM WAS REPORTED WHEN THE REQUEST FOR SERVICE OF THE DEVICE WAS MADE. THE DEVICE WAS FURTHER EVALUATED BY THE MANUFACTURER'S ENGINEERING DEPARTMENT AND EVIDENCE OF NON-DISTILLED WATER INGRESS (IN THE FORM OF WHITE RESIDUE) WAS OBSERVED WITHIN THE DEVICE'S HOUSING. A SMALL THERMAL VOID, LESS THAN 1 MM IN DIAMETER WAS ALSO OBSERVED IN THE BOTTOM ENCLOSURE OF THE DEVICE, DIRECTLY BELOW AN AREA OF THE DEVICE'S PRINTED CIRCUIT ASSEMBLY (PCA) THAT EXHIBITED CORROSION, THERMAL DAMAGE, AND THE AFOREMENTIONED EVIDENCE OF WATER INGRESS. A CPAP DEVICE USED WITH THE HEATED HUMIDIFIER WAS ALSO RETURNED TO THE MANUFACTURER'S SERVICE CENTER. IT WAS FOUND TO BE OPERATIONAL, BUT ALSO EXHIBITED SIGNS OF FLUID INGRESS. BECAUSE THE CPAP DEVICE CAN BE USED WITHOUT A HEATED HUMIDIFIER, IT IS CONCLUDED THAT ITS INVOLVEMENT WITH THE REPORTED EVENT IS ENTIRELY PASSIVE AND AS A RESULT OF THE MISUSE OF THE HUMIDIFIER DEVICE. BECAUSE THE CPAP IS CONCLUDED TO HAVE NOT CONTRIBUTED TO THE HUMIDIFIER FAILURE. BASED ON THE PCA CORROSION BEING CONCURRENT WITH THE EVIDENCE OF WATER INGRESS, THE MANUFACTURER CONCLUDES THE CAUSE OF THE HUMIDIFIER'S PCA FAILURE AND SUBSEQUENT THERMAL EVENT WAS LIKELY RELATED TO IMPROPER CARE, HANDLING AND USE OF THE DEVICE. THE MANUFACTURER CONCLUDES IMPROPER CARE AND HANDLING OF THE HUMIDIFIER OCCURRED BASED ON EVIDENCE OF FLUID INGRESS FOUND INSIDE OF THE DEVICE AND ON ITS PCA. THE MANUFACTURER REVIEWED THE PRODUCT'S LABELING RELATED TO CARE AND HANDLING AND CONCLUDES IT IS ADEQUATE TO PREVENT USE OF THE DEVICE (WITHOUT FIRST DRAINING AND DRYING IT) AFTER ANY INADVERTENT SPILLAGE OF FLUIDS ONTO THE HUMIDIFIER (REF. M SERIES USER MANUAL HEATED HUMIDIFIER, VERSION 01, PART NUMBER 1040469, PAGE 4, SECTION: WARNINGS AND CAUTIONS). THE MANUFACTURER CONCLUDES THE HUMIDIFIER WAS USED IMPROPERLY (WITH NON-DISTILLED H2O) BASED ON THE PRESENCE OF THE WHITE RESIDUE FOUND INSIDE OF THE DEVICE'S HOUSING, AND ON ITS PCA. THE USE OF NON-DISTILLED H2O, WHICH CAN BE BOTH CONDUCTIVE AND CORROSIVE, IS CONTRARY TO PRODUCT LABELING. A REVIEW OF THE DEVICE'S LABELING (M SERIES USER MANUAL HEATED HUMIDIFIER, VERSION 01, PART NUMBER 1040469, PAGE 10, SECTION: DAILY USE) WAS COMPLETED TO VERIFY ITS ADEQUACY. THE MANUFACTURER BELIEVES THIS LABELING, WHICH CLEARLY INFORMS THE USER TO USE ONLY DISTILLED WATER IN THE HUMIDIFIER TANK , IS BOTH ADEQUATE AND APPROPRIATE. THE MANUFACTURER FURTHER ASSESSED THE RISK PRESENTED TO USERS AS A RESULT OF INHALATION OF FUMES PRODUCED AS A RESULT OF THE PCA FAILURE, THE LOSS OF THERAPY, AND FIRE HAZARD. ASSESSMENT OF THE POTENTIAL RISK TO USERS, RESULTING FROM THE INHALATION OF FUMES FROM THE DEVICE'S ELECTRONICS COMPARTMENT (IN THE EVENT OF AN ELECTRICAL FAILURE THAT PRODUCED FUMES), INCLUDED AN ASSESSMENT OF THE DEVICE'S AIR PATH. THE AIR PATH WAS FOUND TO BE COMPROMISED BY THE THERMAL EVENT, AND IT WAS CONCLUDED TO HAVE BEEN EFFECTIVE IN MITIGATING ANY RISK TO THE PRODUCT USER. THE HUMIDIFIER'S INTENDED USE IS FOR HUMIDIFICATION OF CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) THERAPY. THE LOSS OF HUMIDIFICATION MAY RESULT IN DISCOMFORT (DRYNESS TO THROAT) TO THE PATIENT, BUT DOES NOT REPRESENT A SIGNIFICANT RISK OF HARM TO THE INTENDED USER, AND DOES NOT IMPACT CPAP THERAPY FROM BEING DELIVERED TO THE PATIENT. EVALUATION OF THE RISK TO USERS ASSOCIATED WITH FIRE HAZARD INCLUDED AN ASSESSMENT OF THE EFFECTIVENESS IN THE DEVICE'S DESIGN IN MITIGATING THIS HAZARD. THE DEVICE'S HOUSING, MADE OF NON-FLAMMABLE MATERIALS CONFORMING TO UL94-V-0 AND IEC 60601-1 STANDARDS, WAS CONCLUDED TO HAVE BEEN EFFECTIVE IN CONTAINING AND RESISTING ANY SUBSTANTIAL THERMAL INVOLVEMENT ASSOCIATED WITH THE DEVICE'S PCA FAILURE. A COMPLAINT HISTORY REVIEW FOR THE AFFECTED DEVICE FAMILY WAS COMPLETED TO DETERMINE IF THE ISSUE IDENTIFIED IN THIS INVESTIGATION HAD PREVIOUSLY RESULTED IN ANY ADVERSE EVENTS. (B)(4). BASED ON THESE FINDINGS, THE MANUFACTURER CONCLUDES THAT NO FURTHER ACTION IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M-SERIES HEATED HUMIDIFIER CPAP SYSTEM BZD RESPIRONICS INC. 1022334

    Patients

    Seq Age Sex Outcome Treatment
    1 REMSTAR PLUS M, (B)(4)