BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES HEATED HUMIDIFIER

    MDR report key: 1362361 · Received March 26, 2009

    Report

    Report Number
    2518422-2009-00008
    Event Type
    Malfunction
    Date Received
    March 26, 2009
    Date of Event
    February 1, 2009
    Report Date
    February 24, 2009
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BTT
    PMA / PMN Number
    K052110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS EVIDENCE OF THERMAL DAMAGE TO THE PRINTED CIRCUIT ASSEMBLY (PCA), THE HEATER PLATE AND TO THE BOTTOM ENCLOSURE. THE BOTTOM ENCLOSURE HAD TWO VOIDS (1 X 1 MM AND 2 X 0.5 MM), ADJACENT TO A THERMAL EVENT ORIGINATING ON THE PCA. THE DEVICE WAS ALSO FOUND TO BE INOPERABLE DUE TO THE OPENING (PER DESIGN) OF AN INTERNAL FUSE, DESIGNED TO PREVENT FURTHER DAMAGE IN THE EVENT OF THE FAULT CONDITION. THE CPAP DEVICE, RETURNED WITH THE HUMIDIFIER AND ALSO REPORTEDLY AFFECTED BY THE FAILURE, WAS FOUND TO HAVE DAMAGE TO ITS BOTTOM ENCLOSURE. THE SOURCE OF THE DAMAGE COULD NOT BE DETERMINED; HOWEVER, IT APPEARED TO BE FROM AN EXTERNAL SOURCE AND NOT RELATED TO THE HUMIDIFIER FAILURE. INTERNAL EXAMINATION OF THE CPAP DEVICE REVEALED THE PRESENCE OF A WHITE RESIDUE, CHARACTERISTIC OF EVAPORATED TAP WATER, PRESENT ON THE INTERNAL SURFACE OF THE DEVICE'S ENCLOSURE AND ITS PCA AND HEATER PLATE. THE TOP AND BOTTOM SURFACE OF THE PCA ALSO EXHIBITED BOTH SURFACE AND COMPONENT CORROSION. THE PATTERNS OF THE CORROSION APPEAR TO THE CONSISTENT AND RELATED TO THE EVAPORATED TAP WATER DEPOSITS, AND IT IS CONCLUDED THE FLUID INGRESS THAT THE LEFT THE DEPOSITS WAS A CONTRIBUTING FACTOR IN THE DEVICE'S FAILURE. EVALUATION OF THE DEVICE AND INTERVIEWS WITH THE COMPLAINANT DID NOT PROVIDE SUFFICIENT INFORMATION TO DETERMINE THE CAUSE(S) AND PATH OF THE FLUID INGRESS. PRODUCT LABELING PROVIDES USER CARE AND HANDLING INSTRUCTIONS TO PREVENT WATER INGRESS FROM OCCURRING OR AFFECTING THE OPERATION OF THE DEVICE SHOULD IT INADVERTENTLY OCCUR (M SERIES USER MANUAL HEATED HUMIDIFIER, VERSION 01, PART NUMBER 1040469, PAGE 4 SECTION: WARNINGS AND CAUTIONS). THE MANUFACTURER CONCLUDES THE WATER INGRESS AND SUBSEQUENT PRODUCT FAILURE WERE CAUSED AND OR CONTRIBUTED TO BY A FAILURE OF THE PRODUCT USER TO APPLY THE MANUFACTURER'S CARE AND HANDLING INSTRUCTIONS WHEN USING THE DEVICE. PRODUCT LABELING ALSO INSTRUCTS THE USER TO USE ONLY DISTILLED WATER IN THE HUMIDIFIER TANK (M SERIES USER MANUAL HEATED HUMIDIFIER, VERSION 01, PART NUMBER 1040469, PAGE 10, SECTION: DAILY USE). THE PRESENCE OF THE MINERAL DEPOSITS WITHIN THE DEVICE'S HOUSING INDICATES THAT TAP OR OTHER SOURCED NON-DISTILLED WATER WAS REPEATEDLY USED WITH THE DEVICE, CONTRARY TO PRODUCT LABELING, AND SUBSEQUENTLY CONTRIBUTED TO THE PRODUCT FAILURE. 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 NOT FOUND TO BE COMPROMISED BY THE THERMAL EVENT, AND IT WAS CONCLUDED TO HAVE BEEN EFFECTIVE IN MITIGATING ANY RISK TO THE PRODUCT USER. 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 (B)(4) STANDARDS, WAS CONCLUDED TO HAVE BEEN EFFECTIVE IN CONTAINING AND RESISTING ANY SUBSTANTIAL THERMAL INVOLVEMENT ASSOCIATED WITH THE DEVICE'S PCA FAILURE. 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 RISK OF HARM TO THE INTENDED USER. COMPLAINT RECORDS FOR THE AFFECTED DEVICE WERE REVIEWED TO DETERMINE IF THE ISSUE IDENTIFIED IN THIS REPORT HAD PREVIOUSLY OCCURRED AND RESULTED IN AN ADVERSE EVENT. THE COMPLAINT RECORDS REVIEWED WERE RECORDED FROM (B)(4), 2006 (THE DATE THE AFFECTED DEVICE WAS RELEASED FOR DISTRIBUTION) TO (B)(4), 2009. THE REVIEW DETERMINED THAT NO REPORTS OR ALLEGATIONS OF ADVERSE EVENTS ASSOCIATED WITH THIS ISSUE HAD BEEN PREVIOUSLY REPORTED. BASED ON THESE FINDINGS, THE MANUFACTURER CONCLUDES THAT NO FURTHER ACTION IS APPROPRIATE.

    Description of Event or Problem · 1

    THE DURABLE MEDICAL DEVICE (DME) SUPPLIER REPORTED THAT A PATIENT WAS AWAKENED BY AN ODOR AND OBSERVED SMOKE AND SPARKS BEING EMITTED FROM THEIR HUMIDIFIER. NO PATIENT OR USER HARM OR INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR REMSTAR PLUS M SERIES CPAP| (B)(4)