BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR M SERIES

    MDR report key: 1616361 · Received February 24, 2010

    Report

    Report Number
    2518422-2010-00016
    Event Type
    Malfunction
    Date Received
    February 24, 2010
    Date of Event
    January 1, 2010
    Report Date
    January 11, 2010
    Manufacturer
    RESPIRONICS INC
    Product Code
    BZD
    PMA / PMN Number
    K010263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510K: K052110. 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 # 1040469, PAGE 4, SECTION: WARNINGS AND CAUTIONS). THE MFR CONCLUDES THE WATER INGRESS AND SUBSEQUENT PRODUCT FAILURE WERE CAUSED AND/OR CONTRIBUTED TO BY A FAILURE OF THE PRODUCT USER TO APPLY THE MFR'S CARE AND HANDLING INSTRUCTIONS WHEN USING THE DEVICE. PRODUCT LABELING ALSO INSTRUCTS THE USER TO USE ONLY DISTILLED WATER IN THE HUMIDIFIER TANK (M SERIES USER MANUAL HEATED HUMIDIFIER, VERSION 01, PART NUMBER 1040469, PAGE 10, SECTION: DAILY USE); HOWEVER, THE PRESENCE OF THE MINERAL DEPOSITS WITHIN THE DEVICE'S HOUSING INDICATES THAT TAP WATER OR OTHER SOURCED, NON-DISTILLED WATER WAS USED WITH THE DEVICE REPEATEDLY, CONTRARY TO THE PRODUCT LABELING, AND SUBSEQUENTLY CONTRIBUTED TO THE PRODUCT FAILURE. EVAL 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 PT 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 PT AIR PATH BEING COMPROMISED. EVAL OF THE RISK TO USERS ASSOCIATED WITH FIRE HAZARD INCLUDED AN ASSESSMENT OF THE EFFECTIVENESS IN THE DEVICE'S DESIGN 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 CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE IS CLEARED FOR AND INTENDED TO TREAT OBSTRUCTIVE SLEEP APNEA IN SPONTANEOUSLY BREATHING PATIENTS WEIGHING MORE THAN (B)(6). THE LOSS OF CPAP 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), 2010. 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 MFR CONCLUDES THAT NO FURTHER ACTION IS APPROPRIATE.

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT SUPPLIER (DME) REPORTED THAT A CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE (CPAP) WOULD UNEXPECTEDLY SHUT OFF. THERE WAS NO REPORT OF INJURY OR HARM. THE DEVICE WAS RETURNED TO THE MFR'S SERVICE CENTER WHERE EVAL DETERMINED THAT A FAILURE OF THE DEVICE'S PRINTED CIRCUIT ASSEMBLY (PCA) HAD RESULTED IN THERMAL DAMAGE TO THE DEVICE ENCLOSURE IN THE FORM OF A THERMAL VOID. THE MFR'S QUALITY ASSURANCE (QA) DEPT CONFIRMED THE DAMAGE AND DETERMINED THE VOID WAS LOCATED PROXIMAL TO THE THERMALLY DAMAGED PORTION OF THE DEVICE PCA WHICH CONTAINS THE MOTOR-DRIVING CIRCUITRY. EVIDENCE OF FLUID INGRESS, CONSISTENT WITH THE PRECIPITATE RESULTING FROM TAP-WATER EVAPORATION, WAS OBSERVED ON THE PCA IN THE LOCATION OF THE FAILURE AND OTHER AREAS INSIDE THE DEVICE'S HOUSING. THE MFR COMPLETED THE INVESTIGATION OF THE REPORTED FAILURE MODE AND CONCLUDED THE ROOT CAUSE WAS RELATED TO THE PRESENCE OF CONDUCTIVE FLUID, MOST LIKELY TAP WATER, 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. THE MINERAL DEPOSITS AND RESIDUE ON THE DEVICE PCA AND INTERNAL HOUSING EXHIBITED CHARACTERISTICS SUPPORTING A CONCLUSION THAT TAP WATER INGRESS OF THE DEVICE HAD OCCURRED AND CONTRIBUTED TO THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMSTAR M SERIES VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS INC 100S

    Patients

    Seq Age Sex Outcome Treatment
    1