BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-SERIES AC HEATED HUMIDIFIER

    MDR report key: 2059662 · Received March 10, 2011

    Report

    Report Number
    2518422-2011-00033
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 8, 2011
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K052110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER EVALUATED THE DEVICES AND CONFIRMED EVIDENCE OF A THERMAL EVENT HAVING OCCURRED TO THE HUMIDIFIER. THERE WAS DEFORMATION, SMOKE RESIDUE AND THREE SMALL VOIDS IN THE BOTTOM ENCLOSURE OF THE HUMIDIFIER PROXIMAL TO A THERMAL EVENT ON THE DEVICE'S PRINTED CIRCUIT ASSEMBLY (PCA). UPON DISASSEMBLING THE HUMIDIFIER, THE TECHNICIAN DISCOVERED THERMAL DAMAGE TO THE CIRCUIT BOARD MATERIAL AND THE TRACES CONNECTING COMPONENTS J6-F1, AND THE TRACES CONNECTING COMPONENTS C13, CR1, F1, J10 AND RV1. THERE WAS EVIDENCE OF SMOKE RESIDUE IN THE IMMEDIATE AREA OF THE THERMAL EVENT; AND, WHITE RESIDUE, WHICH APPEARS TO BE THE REMAINING MINERALS FROM EVAPORATED TAP WATER, FOUND ON BOTH SIDES OF THE PCA AND THE INTERNAL SURFACES OF THE DEVICE ENCLOSURE. ADDITIONALLY, THE PCA WAS CORRODED ON BOTH ITS TOP AND BOTTOM SURFACES. A WHITE RESIDUE, SIMILAR TO THAT NOTED ABOVE, WAS FOUND IN THE CAVITY FOR THE HUMIDIFIER CHAMBER AND ON THE INTERNAL SURFACES OF THE CHAMBER. THE HUMIDIFIER CHAMBER HAS EVIDENCE OF THERMAL DEFORMATION FROM THE FAILURE ON THE DEVICE PCA. THE MANUFACTURER CONCLUDES THAT IMPROPER CARE AND HANDLING OF THE HUMIDIFIER OCCURRED BASED ON THE EVIDENCE OF FLUID INGRESS FOUND INSIDE THE DEVICE AND ON THE PCA. THE MANUFACTURER REVIEWED THE PRODUCT'S LABELING, RELATED TO CARE AND HANDLING, AND CONCLUDES THE LABELING IS ADEQUATE TO PREVENT THE USE OF THE DEVICE (WITHOUT FIRST DRAINING AND DRYING IT) AFTER ANY INADVERTENT SPILLAGE OF FLUIDS ONTO THE HUMIDIFIER, TO PREVENT THE USE OF A DAMAGED DEVICE AND TO PREVENT THE DEVICE BEING PLACED IN OR ON ANY CONTAINER THAT CAN COLLECT OR HOLD WATER (REF. M SERIES USER MANUAL HEATED HUMIDIFIER, VERSION 01, PART NUMBER 1040469, PAGES 3-4, SECTION: WARNINGS AND CAUTIONS). THE MANUFACTURER FURTHER CONCLUDES THE HUMIDIFIER WAS USED IMPROPERLY (WITH NON-DISTILLED WATER), BASED ON THE PRESENCE OF THE WHITE RESIDUE FOUND INSIDE OF THE DEVICE'S HOUSING AND ON ITS PCA. THE USE OF NON-DISTILLED WATER, 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 HUMIDIFIER'S INTENDED USE IS FOR HUMIDIFICATION OF CPAP THERAPY. THE LOSS OF HUMIDIFICATION MAY RESULT IN DISCOMFORT TO THE PATIENT (DRYNESS TO THROAT) 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 (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 MANUFACTURER ALSO ASSESSED THE RISK PRESENTED TO USERS AS A RESULT OF ANY 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 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. 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. THE REVIEW, INCLUDING COMPLAINT RECORDS RECORDED BETWEEN (B)(6) 2006 (THE DATE THE AFFECTED DEVICE WAS RELEASED FOR DISTRIBUTION) AND (B)(6) 2011 IDENTIFIED NO COMPLAINT RECORDS ASSOCIATED WITH ADVERSE EVENTS. BASED ON THESE FINDINGS, THE MANUFACTURER CONCLUDES THAT NO FURTHER ACTION IS NECESSARY. METHOD: HISTORICAL REVIEW OF AFFECTED COMPLAINT RECORDS.

    Description of Event or Problem · 1

    A (B)(6) REPORTED THAT AN AC HEATED HUMIDIFIER WAS EMITTING AN ELECTRICAL OR BURNING PLASTIC ODOR AND APPEARED MELTED ON THE WATER CHAMBER AND THE BOTTOM ENCLOSURE. THE (B)(6) REPORTED THAT THE DEVICE WOULD NOT WORK. THERE WAS NO REPORT OF PATIENT INJURY OR HARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR