Events

Rappel de BariAir Therapy System

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 KCI USA, 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
    62979
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2466-2012
  • Date de mise en oeuvre de l'événement
    2012-09-17
  • Date de publication de l'événement
    2012-09-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112188
  • 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
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Cause
    Kci has issued a medical device correction for the bariair therapy system hand pendent. the bariair therapy system is not designed to allow the patient to place the bed into the patient exit position. kci has received complaints indicating that patients used the hand pendent to inadvertently place the bariair therapy system into a pseudo-exit position. in a small number of instances, this allow.
  • Action
    KCI sent an Urgent - Voluntary Medical Device Correction letter dated September 13, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers would be contacted by KCI to coordinate a shipment of a replacement product. For questions customers would instructed to call 1-800-275-4524, Select Option 3 followed by Option 2. For questions regarding this recall call 1-800-275-4524.

Device

BariAir Therapy System
  • Modèle / numéro de série
    Multiple Serial Numbers with Model Numbers: 404000,405500, 405500RF
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.
  • Description du dispositif
    BariAir Therapy System || The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient positioning capabilities and built-in scales for patients weighing 300 Ib* to 850 Ib ([136*-386 kg] including accessories). The BariAir Therapy System is indicated to aid in: " Patients whose body weight and size pose a significant risk or care management issue to the patient or staff during the performance of routine nursing care. " Large patients weighing between 300 Ib* and 850 Ib (136*-386 kg) including accessories. " Large patients who are difficult to turn. " Preventing and treating pressure ulcers. " Large patients requiring percussion therapy.
  • Manufacturer
    KCI USA, Inc.

Manufacturer

KCI USA, Inc.
  • Adresse du fabricant
    KCI USA, Inc., 4958 Stout Dr, San Antonio TX 78219-4334
  • Source
    USFDA