BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-SERIES (AC) HEATED HUMIDIFIER

    MDR report key: 1995749 · Received January 20, 2011

    Report

    Report Number
    2518422-2011-00007
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 21, 2010
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K052110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR 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, EVIDENCE WAS FOUND OF THERMAL DAMAGE TO THE CIRCUIT BOARD MATERIAL AND THE TRACES CONNECTING COMPONENTS 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, 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 INTERNAL SURFACE OF THE TOP ENCLOSURE OF THE HUMIDIFIER WAS THERMALLY DAMAGED PROXIMAL TO THE PCA THERMAL EVENT; BUT, THE DAMAGE IS NOT VISIBLE EXTERNALLY. HISTORICAL REVIEW OF AFFECTED COMPLAINT RECORDS. THE OPERATION OF THE ASSOCIATED BI-LEVEL POSITIVE AIRWAY PRESSURE DEVICE (BIPAP) WAS NOT ADVERSELY AFFECTED BY THE FAILURE OF THE HUMIDIFIER. BECAUSE THE BIPAP DEVICE CAN BE USED WITHOUT A HEATED HUMIDIFIER AND SHOWS NO EVIDENCE OF FAILURE OR THERMAL DAMAGE, THE MFR FINDS THAT ITS INVOLVEMENT WITH THE REPORTED EVENT WAS ENTIRELY PASSIVE. THE MFR CONCLUDES THAT THE BIPAP DID NOT CONTRIBUTE TO THE HUMIDIFIER FAILURE. THE MFR 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 MFR 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 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 MFR 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 MFR BELIEVES THIS LABELING, WHICH CLEARLY INFORMS THE USER TO USE ONLY DISTILLED WATER IN THE HUMIDIFIER TANK, IS BOTH ADEQUATE AND APPROPRIATE. THE MFR 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 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 CPAP THERAPY. THE LOSS OF HUMIDIFICATION MAY RESULT IN DISCOMFORT TO THE PT (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 PT. 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)(4) 2011 IDENTIFIED NO COMPLAINT RECORDS ASSOCIATED WITH ADVERSE EVENTS. BASED ON THESE FINDINGS, THE MFR CONCLUDES THAT NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT SUPPLIER (DME) REPORTED THAT THE PT WAS AWAKENED BY AN ODOR AND FOUND PART OF THE BOTTOM OF THE M-SERIES HEATED HUMIDIFIER APPEARED TO HAVE MELTED NEAR THE POWER CORD CONNECTION, COMPROMISING THE ENCLOSURE. 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 65 YR OXYGEN CONCENTRATOR| BIPAP AUTO M-SERIES, 700M, (B)(4)