BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-SERIES (AC) HEATED HUMIDIFIER

    MDR report key: 1918529 · Received November 5, 2010

    Report

    Report Number
    2518422-2010-00124
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 6, 2010
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K052110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORICAL REVIEW OF AFFECTED COMPLAINT RECORDS. THE MANUFACTURER EVALUATED THE DEVICES AND CONFIRMED THERE IS EVIDENCE OF A THERMAL EVENT HAVING OCCURRED TO THE HUMIDIFIER. THERE WAS DEFORMATION, SMOKE RESIDUE AND A THERMAL VOID IN THE BOTTOM ENCLOSURE OF THE HUMIDIFIER, PROXIMAL TO A THERMAL EVENT ON THE DEVICE'S PRINTED CIRCUIT ASSEMBLY (PCA). UPON DISASSEMBLING THE HUMIDIFIER, EVIDENCE WAS FOUND OF THERMAL DAMAGE TO THE PCA TRACES CONNECTING COMPONENTS C13, CR1, F1, J3, 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, WAS FOUND ON BOTH SIDES OF THE PCA AND THE INTERNAL SURFACES OF THE ENCLOSURE. ADDITIONALLY, THE PCA WAS CORRODED ON BOTH ITS TOP AND BOTTOM SURFACES. THE OPERATION OF THE ASSOCIATED CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE (CPAP) WAS NOT ADVERSELY AFFECTED BY THE FAILURE OF THE HUMIDIFIER. THE DEVICE PASSED ALL OPERATIONAL TESTING AND NO PROBLEMS WERE FOUND. BECAUSE THE CPAP DEVICE CAN BE USED WITHOUT A HEATED HUMIDIFIER AND SHOWS NO EVIDENCE OF THERMAL DAMAGE, THE MANUFACTURER CONCLUDES THAT ITS INVOLVEMENT WITH THE REPORTED EVENT WAS ENTIRELY PASSIVE. THE CPAP IS CONCLUDED TO HAVE NOT CONTRIBUTED TO THE HUMIDIFIER FAILURE; 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 ITS PCA. THE MANUFACTURER REVIEWED THE PRODUCT'S LABELING, RELATED TO CARE AND HANDLING, AND CONCLUDES IT 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 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 O-RING SEAL OF THE WATER CHAMBER WAS DETERMINED TO HAVE BEEN ROLLED OUT OF PLACE AT THE TIME OF THE MANUFACTURER'S EVALUATION AND MAY HAVE CONTRIBUTED TO THE SEVERITY OF THE WATER INGRESS, HOWEVER, THE MANUFACTURER CANNOT DETERMINE IF THE O-RING WAS ROLLED OUT OF PLACE DURING CUSTOMER USE. 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 MANUFACTURER FURTHER 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 RISKS 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. 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 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. THE REVIEW, INCLUDING COMPLAINT RECORDS RECORDED BETWEEN 01/01/2016 (THE DATE THE AFFECTED DEVICE WAS RELEASED FOR DISTRIBUTION) AND 11/04/2010 IDENTIFIED NO COMPLAINT RECORDS ASSOCIATED WITH ADVERSE EVENTS. BASED ON THESE FINDINGS, THE MANUFACTURER CONCLUDES THAT NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT SUPPLIER (DME) REPORTED THAT A HEATED HUMIDIFIER DEVICE HAD STARTED TO SPARK AND UNPLUGGED IT. THE PATIENT REPORTED THAT THE EVENT STOPPED AS SOON AS THE DEVICE WAS UNPLUGGED. THERE WAS NO REPORT OF 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