BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRATORY GAS HUMIDIFIER- FOR USE WITH BREATHING GASES

    MDR report key: 2142392 · Received June 21, 2011

    Report

    Report Number
    1525712-2011-00283
    Event Type
    Injury
    Date Received
    June 21, 2011
    Report Date
    June 20, 2011
    Manufacturer
    INVACARE
    Product Code
    BTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALLEGED MALFUNCTION. ALLEGED MEDICAL INTERVENTION. ALLEGEDLY, 2 YEARS AGO THE CONSUMER WAS HOSPITALIZED FOR A DAY BECAUSE OF WATER ENTERING HER LUNGS AFTER USING THE DEVICE. ALLEGEDLY, THE HUMIDIFIER BOTTLE HAD MOISTURE BUILT UP AND WATER WAS DRIPPING OUT OF THE CONSUMERS NOSE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION OBTAINED FROM THE DEALER. THE DEALER STATED THAT THE UNIT HAS BEEN REPLACED 3 TIMES FOR THIS ISSUE. THE DEALER STATED THE CONSUMER HAS BEEN KNOWN TO OVERFILL THEIR HUMIDIFIER BOTTLES. IN ADDITION, THE CONSUMER USES A LENGTH OF TUBING 50 FT LONG INSTEAD OF THE RECOMMENDED 25 FT LENGTH. THE LONG LENGTH OF TUBING CAUSES THE TUBING TO REST ON THE FLOOR WHERE CONDENSATION ACCUMULATES. ALSO, THE CONSUMER HAS BEEN KNOWN TO HAVE DAMAGED UNITS IN THE PAST. THE ISSUE APPEARS TO BE A OPERATOR ERROR. MDR TO BE UPDATES TO REFLECT THE NEW INFORMATION.

    Description of Event or Problem · 1

    THE CONSUMER STATES THAT APPROXIMATELY 2 YEARS AGO, SHE WAS ALLEGEDLY HOSPITALIZED FOR A DAY BECAUSE OF WATER ENTERING HER LUNGS. THIS WAS ALLEGEDLY CAUSED BY THE HUMIDIFIER BOTTLE MOISTURE BUILDING UP AND WATER DRIPPING OUT OF HER NOSE. THE DEALER SPOKE TO IVC TECH SERVICES WHO SUGGESTED THE CONSUMER GET A WATER TRAP AND KEEP THE CORD OFF THE FLOOR AS MUCH AS POSSIBLE. THE DEALER HAS REPLACED THE UNIT TWICE, BUT THE CONSUMER CONTINUES TO HAVE AN ISSUE.

    Description of Event or Problem · 1

    THE CONSUMER STATES THAT APPROXIMATELY 2 YEARS AGO, SHE WAS ALLEGEDLY HOSPITALIZED FOR A DAY BECAUSE OF WATER ENTERING HER LUNGS. THIS WAS ALLEGEDLY CAUSED BY THE HUMIDIFIER BOTTLE MOISTURE BUILDING UP AND WATER DRIPPING OUT OF HER NOSE. THE DEALER SPOKE TO IVC TECH SERVICES WHO SUGGESTED THE CONSUMER GET A WATER TRAP AND KEEP THE CORD OFF THE FLOOR AS MUCH AS POSSIBLE. THE DEALER HAS REPLACED THE UNIT TWICE, BUT THE CONSUMER CONTINUES TO HAVE AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY GAS HUMIDIFIER- FOR USE WITH BREATHING GASES 868.5450 BTT INVACARE IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R