BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAPOTHERM

    MDR report key: 808181 · Received November 23, 2004

    Report

    Report Number
    1125759-2004-00001
    Event Type
    Other
    Date Received
    November 23, 2004
    Date of Event
    October 1, 2004
    Report Date
    November 23, 2004
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILTIY REPORTED, UNSPECIFIED MALFUNCTION OF VAPOTHERM UNIT OVER 7 HRS, WITH INCREASING DESATURATION IN A MALE NEONATAL PT. PT CONDITION IMPROVED IMMEDIATELY WHEN VAPOTHERM UNIT WAS REPLACED WITH A UNIT THAT WAS WORKING CORRECTLY. VAPOTHERM WAS NOT NOTIFIED OF A REPORTABLE INCIDENT. THE UNIT WAS SUBSEQUENTLY SENT FOR REPAIR (2004) WITH A COMPLAINT THAT IT FAILED TO ALARM IN THE ABSENCE OF GAS FLOW. THE BIOMEDICAL TECHNICIAN WAS UNABLE TO CONFIRM THE USER COMPLAINT, BUT FOUND USER-RELATED DAMAGE TO A GAS TUBE THAT COULD HAVE LED TO THE REPORTED PT DESATURATION. THE TUBE WAS REPLACED. IN ADDITION, AN INTERNAL SENSOR WAS REPLACED AS A PREVENTIVE MEASURE, AND SOME INTERNAL CORROSION WAS REMOVED. THESE WERE UNRELATED TO THE PT EVENT. THE UNIT PASSED PRE-SHIPPING INSPECTION AND WAS RETURNED TO THE HOSP THE NEXT DAY.

    Description of Event or Problem · 1

    HOSP REPORTED UNSPECIFIED MALFUNCTION ASSOCIATED WITH PROGRESSIVE OXYGEN DESATURATION IN PT. MALFUNCTIONING UNIT WAS REPLACED AFTER 7 HRS WITH IMMEDIATE IMPROVEMENT IN PT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOTHERM RESPIRATORY THERAPY DEVICE BTT VAPOTHERM, INC. 2000I *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other