BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M SERIES HEATED HUMIDIFIER

    MDR report key: 3913019 · Received June 11, 2014

    Report

    Report Number
    2518422-2014-00828
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K072996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AN END USER ALLEGED THAT AN M SERIES HEATED HUMIDIFIER HAS NOT BEEN PROVIDING SUFFICIENT HUMIDIFICATION FOR SEVERAL YEARS. THE END USER ALLEGES THE ABSENCE OF HUMIDIFICATION HAS CAUSED DRY MOUTH AND TOOTH DECAY, REQUIRING THE REMOVAL OF TEETH. THE HUMIDIFIER WAS DISCARDED BY THE END USER AND IS NOT AVAILABLE FOR EVALUATION BY THE MANUFACTURER. THE MANUFACTURER CONTACTED THE DURABLE MED EQUIPMENT SUPPLIER (DME) FOR ADDITIONAL INFORMATION. CLINICAL NOTES PROVIDED BY THE DME INDICATE THAT ON (B)(6) 2009 THE END USER SAID "YES" TO A DRY MOUTH QUESTION ON THEIR QUESTIONNAIRE, AND HE WAS INSTRUCTED ON PROPER USE OF THE HUMIDIFIER. SINCE 2009, THE DME REPORTED THE END USER ON MULTIPLE VISITS MARKED "NO" TO A DRY MOUTH QUESTION ON THE QUESTIONNAIRE. THE DME WAS NOT MADE AWARE OF ANY OTHER ISSUES BY THE END USER, AND HE DID NOT REPORT ANY VISUAL ALERTS FROM THE BIPAP OR HUMIDIFIER LED INDICATORS THAT THERE WAS A PROBLEM WITH THE DEVICE. DATA PROVIDED BY THE DME INDICATES THE HUMIDIFIER WAS OPERATED WITH A HEATED SETTING FROM (B)(6) 2008 UNTIL A POINT IN 2010 WHEN IT WAS OPERATING IN A "PASSIVE" MODE WITHOUT HEAT. WITHOUT THE ABILITY TO EVALUATE THE HUMIDIFIER, SINCE IT WAS DISCARDED BY THE PATIENT, THE MANUFACTURER IS UNABLE TO DETERMINE IF THERE WAS A FAILURE OF THE DEVICE, OR IF THE END USER CHOSE TO USE IT WITHOUT THE HEATED OPTION. THE USER MANUAL FOR THE HUMIDIFIER STATES, "NEVER OPERATE THE HUMIDIFIER IF ANY OF THE PARTS ARE DAMAGED, IF IT IS NOT WORKING PROPERLY, OR IF THE HUMIDIFIER HAS BEEN DROPPED OR MISHANDLED. HAVE ANY DAMAGED PARTS REPLACED BEFORE CONTINUING USE." BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER COULD NOT CONCLUDE A DEVICE MALFUNCTION AND CONCLUDES A POTENTIAL USER ERROR CONTRIBUTED TO THE EVENT AND NO FURTHER ACTION IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344047 M SERIES HEATED HUMIDIFIER VENTILATOR, NON-CONTINUOUS RESPIRATOR BZD RESPIRONICS INC. 1051158

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other AUTO M SERIES, (B)(4)| BILEVEL POSITIVE AIRWAY PRESSURE DEVICE (BIPAP)