BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISION FLOW DISPOSABLE PATIENT CIRCUIT

    MDR report key: 2061290 · Received April 12, 2011

    Report

    Report Number
    1125759-2011-00004
    Event Type
    Other
    Date Received
    April 12, 2011
    Date of Event
    March 8, 2011
    Report Date
    April 12, 2011
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED IN MEDWATCH THAT THE DISPOSABLE PT CIRCUIT (DPC) WAS OBSERVED TO BE LEAKING WATER AT THE BOTTOM. THIS WAS OBSERVED AT EQUIPMENT SET UP WITHOUT PT INVOLVEMENT. THE EVENT WAS REPORTED TO VAPOTHERM ON (B)(6) 2011. AT THAT TIME, THE HOSPITAL REPORTED THE WATER LEAKAGE WAS FROM THE DPC TOP CAP. AT THE DATE OF THIS REPORT, NO PRODUCT HAS BEEN RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION FLOW DISPOSABLE PATIENT CIRCUIT HUMIDIFIER BTT VAPOTHERM, INC. PF-DPC-LOW LF1102013

    Patients

    Seq Age Sex Outcome Treatment
    1