BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES HEATED HUMIDIFIER

    MDR report key: 1113285 · Received August 8, 2008

    Report

    Report Number
    2518422-2008-00021
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 9, 2008
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BTT
    PMA / PMN Number
    K012633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN TO THE MANUFACTURER FOR INVESTIGATION OF THE ALLEGED EVENT, A VISUAL EXAMINATION OF THE DEVICE REVEALED A RESIDUE ON THE INTERNAL HOUSING SURFACES AND ON THE DEVICE'S ELECTRONIC PRINTED CIRCUIT ASSEMBLY (PCA). THE RESIDUE ON THE INTERNAL HOUSING OF THE DEVICE IS CHARACTERISTIC OF MINERAL DEPOSITS THAT RESULT AFTER THE EVAPORATION OF TAP WATER. THE MFR CONCLUDES THAT THE DEVICE HAS EXPERIENCED WATER INGRESS, BUT CANNOT CONFIRM THE SOURCE OF THE INGRESS OR SUBSTANTIATE IT OCCURRED AS A RESULT OF THE OVERFILLING OF THE WATER CHAMBER OR IMPROPER HANDLING OF THE DEVICE DURING THE FILLING OF THE DEVICE'S WATER CHAMBER. THE MANUFACTURER EVALUATED THE HUMIDIFIER CHAMBER RETURNED WITH THE DEVICE TO CONFIRM THE CUSTOMER'S ALLEGATION THAT THE CHAMBER WAS LEAKING. THE CHAMBER INLET AND OUTLET SEALS AND O-RING WERE FOUND TO FUNCTION AS DESIGNED AND THEIR INTEGRITY WAS NOT COMPROMISED. THE SOURCE OF THE FLUID INGRESS INTO THE INTERNAL HOUSING SURFACES AND PCA WAS CONCLUDED TO NOT BE ASSOCIATED WITH THE WATER CHAMBER THAT WAS RETURNED WITH THE DEVICE. FURTHER EVALUATION OF THE DEVICE REVEALED ITS PCA WAS DAMAGED BY CORROSION ON BOTH TOP AND BOTTOM SURFACES AND IS INOPERATIVE AS RECEIVED BY QUALITY ASSURANCE. AN AREA OF THE PCA PROXIMAL TO THE J3 CONNECTOR AND APPROXIMATELY 1/4 SQ INCH IN AREA WAS FOUND TO EXHIBIT THERMAL DAMAGE. THIS CORROSION AND THE THERMAL EVENT APPEAR TO BE RELATED TO THE FLUID INGRESS THAT THE DEVICE HAS BEEN EXPOSED TO. THE ENCLOSURE OF THE DEVICE, DESIGNED IN ACCORDANCE WITH UL AND IEC REQUIREMENTS FOR FIRE RETARDANT MATERIALS, EXHIBITED NO EVIDENCE. IT WAS AFFECTED BY THE THERMAL EVENT WHICH AFFECTED THE PCA. THE MFR'S CONCLUSION REGARDING THE ALLEGED SHOCK IS THAT THERE IS INSUFFICIENT EVIDENCE TO SUBSTANTIATE THE EVENT OCCURRED, BASED ON THE LIMITED INFORMATION PROVIDED TO THE MANUFACTURER. HOWEVER, THE DEVICE ASSOCIATED WITH THIS EVENT IS DESIGNED TO BE USED WITH DISTILLED H2O, WHICH MINIMIZES THE RISK OF CONDUCTIVITY AND CORROSION ISSUES, SHOULD A CUSTOMER MISHANDLE THE DEVICE IN A MANNER THAT RESULTS IN FLUID INGRESS INTO THE DEVICE. THE DEVICE ALSO HAS A NON-CONDUCTIVE PLASTIC HOUSING TO MINIMIZE THE POTENTIAL FOR A USER TO MAKE CONTACT WITH A CONDUCTIVE SURFACE. A REVIEW OF THE MFR'S COMPLAINT DATABASE FOR THE DEVICE ASSOCIATED WITH THIS EVENT, FOR THE TWO YEAR PERIOD FOLLOWING ITS RELEASE IN FEBRUARY 2006 REVEALED NO INCREASING TRENDS IN COMPLAINTS RELATED TO LEAKING AND NO REPORTS ALLEGING ELECTRICAL SHOCKS. BASED ON THESE FINDINGS AND AVAILABLE DATA THE MFR HAS CONCLUDED THAT NO FURTHER ACTION IS APPROPRIATE.

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER REPORTED ONE OF THEIR CUSTOMERS ALLEGED RECEIVING A SHOCK WHILE USING A HEATED HUMIDIFIER. NO PATIENT HARM, INJURY OR MEDICAL INTERVENTION WAS REPORTEDLY ASSOCIATED WITH THIS EVENT. WHEN CONTACTED BY THE MFR, THE DME WOULD NOT PROVIDE THE MFR THEIR CUSTOMER'S CONTACT INFORMATION. HOWEVER, THE DME DID INFORM THE MFR THAT THE CUSTOMER WAS USING THE DEVICE AT THE TIME OF THE EVENT AND THAT THE CUSTOMER HAD PLACED THEIR HUMIDIFIER IN A METAL PAN TO CONTAIN WATER THAT WAS LEAKING FROM IT, AND RECEIVED A SHOCK WHEN THEY TOUCHED THE DEVICE WHILE IT WAS IN THIS METAL PAN. THE DME WAS UNABLE TO CONFIRM THE PRESENCE OF FLUID IN THE METAL PAN AT THE TIME OF THE EVENT. THE DME ALSO INFORMED THE MFR THAT THE CUSTOMER WAS NOT USING DISTILLED WATER TO FILL THE HUMIDIFIER CHAMBER. THE MFR INFORMED THE DME THAT THE DEVICE IS ONLY TO BE USED WITH DISTILLED WATER, AS INDICATED IN PRODUCT LABELING (REF USER MANUAL PN 1028932, REV 02, 11/06/2005). THE DME WAS ALSO INFORMED BY THE MANUFACTURER THAT THEIR CUSTOMERS SHOULD NOT USE THE HUMIDIFIER IF THE WATER CHAMBER IS LEAKING OR DAMAGED IN ANY WAY, OR USE A PAN TO CONTAIN WATER LEAKING FROM A DEVICE. THE DME WAS MADE AWARE THAT PRODUCT USER MANUAL FOR THIS DEVICE INFORMS THE USER TO HAVE ANY DAMAGED PARTS REPLACED BEFORE CONTINUING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES HEATED HUMIDIFIER HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE). BTT RESPIRONICS, INC. 1022334

    Patients

    Seq Age Sex Outcome Treatment
    1 REMSTAR PLUS M SERIES ASSEMBLY CPAP