BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-SERIES HEATED HUMIDIFIER (AC)

    MDR report key: 1632269 · Received March 3, 2010

    Report

    Report Number
    2518422-2010-00018
    Event Type
    Malfunction
    Date Received
    March 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    January 28, 2010
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K052110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS: HISTORICAL REVIEW OF AFFECTED COMPLAINT RECORDS.

    Description of Event or Problem · 1

    THE DURABLE MEDICAL EQUIPMENT SUPPLIER (DME) REPORTED THAT THE DEVICE WAS EMITTING AN ELECTRICAL OR BURNING PLASTIC ODOR AND NOT OPERATING. THERE WAS NO REPORT OF VISIBLE THERMAL DAMAGE TO THE DEVICE. HOWEVER, WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURER, THE INITIAL EVALUATION DETERMINED THAT A THERMAL VOID EXISTED IN THE DEVICE ENCLOSURE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS EVALUATED BY THE MANUFACTURER'S QUALITY ASSURANCE DEPARTMENT. THE COMPLAINT OF THE DEVICE EMITTING AN ELECTRICAL OR BURNING PLASTIC ODOR AND NOT OPERATING WAS CONFIRMED. THERE WAS EVIDENCE OF WATER INGRESS, CORROSION AND THERMAL DAMAGE TO THE PRINTED CIRCUIT ASSEMBLY (PCA). PROXIMAL TO THE THERMAL DAMAGE WAS A PIN-HOLE SIZED, THERMAL VOID IN THE BOTTOM ENCLOSURE OF THE DEVICE. A WHITE RESIDUE, CONSISTENT WITH THE REMAINING MINERALS FROM EVAPORATED TAP WATER, WAS FOUND IN THE CAVITY FOR THE WATER TANK, ON BOTH SIDES OF THE PCA AND THE INTERNAL SURFACES OF THE ENCLOSURES. THE TANK HAD EVIDENCE OF LEAKING AND A ROLLED O-RING. THE ASSOCIATED BI-LEVEL POSITIVE AIRWAY PRESSURE DEVICE (BIPAP) WAS ALSO EVALUATED BY THE MANUFACTURER'S SERVICE CENTER AND PASSED ALL OPERATIONAL TESTING. NO PROBLEMS WERE FOUND. THE MANUFACTURER CONCLUDES 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 IF IT IS DAMAGED OR LEAKING (WITHOUT HAVING DAMAGED PARTS REPLACED) OR AFTER ANY INADVERTENT SPILLAGE OF FLUIDS (WITHOUT FIRST DRAINING AND DRYING IT) ONTO THE HUMIDIFIER (REF. M SERIES USER MANUAL HEATED HUMIDIFIER, VERSION 01, PART NUMBER 1040469, PAGE 3-4, SECTION: WARNINGS AND CAUTIONS). THE MANUFACTURER FURTHER 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 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. THE HUMIDIFIER'S INTENDED USE IS FOR HUMIDIFICATION OF CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP OR BIPAP) 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 BIPAP 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. 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 JANUARY 01, 2006 (THE DATE THE AFFECTED DEVICE WAS RELEASED FOR DISTRIBUTION) AND MARCH 3, 2010 IDENTIFIED NO COMPLAINT RECORDS ASSOCIATED WITH REPORTABLE ADVERSE EVENTS. 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 (AC) CPAP SYSTEM BZD RESPIRONICS INC. 1022334

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR M-SERIES BIPAP PLUS, 600M, (B)(4)