BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP AUTO M-SERIES

    MDR report key: 2117259 · Received May 20, 2011

    Report

    Report Number
    2518422-2011-00056
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 21, 2011
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K061034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MANUFACTURER'S ENGINEERING DEPARTMENT. THE COMPLAINT OF THE DEVICE HAVING A THERMAL VOID IN THE TOP ENCLOSURE WAS CONFIRMED. THERE WERE SIGNS OF WATER INGRESS TO THE THERAPY PRINTED CIRCUIT ASSEMBLY (PCA), THE SENSOR PCA, THE BLOWER AND THE FOAM OF THE BOTTOM ENCLOSURE. THERE WAS EVIDENCE OF THERMAL DAMAGE TO COMPONENTS Q9, Q15 AND Q16 ON THE THERAPY PCA. THERMAL FAILURE OF THE PCA COMPONENTS RESULTED IN A VOID IN THE TOP ENCLOSURE OF THE DEVICE. THE MANUFACTURER COMPLETED THEIR INVESTIGATION OF THE REPORTED COMPLAINT AND HAS CONCLUDED THE FAILURE MODE IS CAUSED BY THE PRESENCE OF CONDUCTIVE FLUID AT THE LOCATION OF THE MOTOR DRIVING FIELD EFFECT TRANSISTORS (FET) ON THE DEVICE'S THERAPY PCA. CONDUCTIVE FLUID IN THIS LOCATION CAN, IN SOME CASES, ALLOW ELECTRICAL CURRENT FLOW BETWEEN THE PINS AND COMPONENTS OF THE MOTOR DRIVING CIRCUIT, CAUSING THE CONTROLLING TRANSISTOR TO CONTINUOUSLY POWER ONE OR MORE OF THE MOTOR-DRIVING FETS. CONTINUOUS POWER TO THE MOTOR-DRIVING FETS CAN CAUSE AN INCREASE IN COMPONENT HEAT WHICH CANNOT BE DISSIPATED EFFECTIVELY THROUGH THE COMPONENT'S HEAT SINK. THE INCREASED HEAT CAN CAUSE DEFORMATION AND, POTENTIALLY, VOIDS IN THE DEVICE ENCLOSURE. ADDITIONAL PMA510(K)#: K050759. METHOD: REVIEW OF COMPLAINT DATABASE. THE CAUSE(S) AND PATH OF THE FLUID INGRESS COULD NOT BE DETERMINED; HOWEVER, THE PRODUCT'S 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. EVALUATION OF THE RISK TO USERS RESULTING FROM THE ADULTERATION OF THE DEVICE'S AIR WAY INCLUDED AN ASSESSMENT OF THE DEVICE'S AIR PATH. THE DEVICE'S PATIENT AIR PATH, WHICH IS ISOLATED FROM THE ELECTRONICS COMPARTMENT, WAS FOUND TO BE NON-COMPROMISED AND IS CONCLUDED TO HAVE BEEN EFFECTIVE IN MITIGATING ANY RISK TO THE PRODUCT USER THAT MAY HAVE RESULTED FROM THE DEVICE'S PATIENT AIR PATH BEING COMPROMISED. 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 BI-LEVEL POSITIVE AIRWAY PRESSURE (BIPAP) DEVICE IS CLEARED FOR AND INTENDED TO TREAT OBSTRUCTIVE SLEEP APNEA IN SPONTANEOUSLY BREATHING PATIENTS WEIGHING MORE THAN (B)(6). THE LOSS OF BIPAP THERAPY DOES NOT REPRESENT A SIGNIFICANT RISK OF HARM TO THE INTENDED USER POPULATION. 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)(6) 2006 (THE DATE THE AFFECTED DEVICE WAS RELEASED FOR DISTRIBUTION) TO (B)(6) 2011. THE REVIEW DETERMINED THAT NO REPORTS OR ALLEGATIONS OF ADVERSE EVENTS ASSOCIATED WITH THIS ISSUE HAD BEEN PREVIOUSLY REPORTED. BASED ON THE INVESTIGATION AND THESE FINDINGS, THE MANUFACTURER CONCLUDES THAT NO FURTHER ACTION IS APPROPRIATE.

    Description of Event or Problem · 1

    A (B)(6) REPORTED THAT A PATIENT HAD FOUND A THERMAL VOID IN THE TOP ENCLOSURE OF A RESPIRONICS BIPAP AUTO M-SERIES DEVICE. THERE WAS NO REPORT OF INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPAP AUTO M-SERIES VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 700M

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR M-SERIES AC HEATED HUMIDIFIER: (B)(4)