Events

Rappel de Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis, MD 21401***.

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Vapotherm, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    33935
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0360-06
  • Date de mise en oeuvre de l'événement
    2005-10-13
  • Date de publication de l'événement
    2006-01-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-08-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42761
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Humidifier, Respiratory Gas, (Direct Patient Interface) - Product Code BTT
  • Cause
    A medical device firm changed the labeling of its respiratory gas humidifier by revising the protocol for higher level disinfectants to be used by healthcare practitioners.
  • Action
    Vapotherm, Inc. reportedly notified distributors and institutional end users via subscriber list-serve with newsletters sent on 10/13/05, 10/31/05 and 11/04/05. The notifications addressed the CDC epidemiological study, in which no definitive information on the source of the organism was identified. The notice states that the firm continued to recommend disinfection between patients and adherence to FDA limitations on the re-use of single patient consumables. Subsequently, Vapotherm reported that they had developed an enhanced disinfecting protocol including a recommendation for using higher level disinfectants and the use of sterile water in the system. The notification refers consignees to the company website for infection prevention and control resources updates. On 12/20/05, Vapotherm notified their list-serve subscribers that they were recalling 2000i devices to conduct a high level disinfectant protocol with the devices to be returned to end users with newly revised labeling to include recommendation for sterile water use and device components designed to provide humidification within a closed system. On 12/22/05, Vapotherm notified distributors and healthcare practitioners via certified mail flagged 'Urgent'. The firm's notification was reportedly sent to hospital respiratory and infection control departments and advised that other therapies, such as nasal CPAP and standard oxygen therapies should be considered during the recall. The notification directs users to the firm's website where users may log on and obtain return authorization for shipping back to the recalling firm. A response form is included with the notification and users are requested to fax back for confirmation of notification.

Device

Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis,...
  • Modèle / numéro de série
    All S/Ns of the Vapotherm" Model 2000i are affected.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Products were sold to medical device distributors and end users nationwide and in international markets.
  • Description du dispositif
    Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis, MD 21401***.
  • Manufacturer
    Vapotherm, Inc.

Manufacturer

Vapotherm, Inc.
  • Adresse du fabricant
    Vapotherm, Inc., 198 Log Canoe Circle, Stevensville MD 21666-2128
  • Source
    USFDA