Events

Alerte De Sécurité sur Surgical Light Model P1350 Press Surgical Light. Distributed Units in US and Internationally

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Hill-Rom Co Inc A Hillenbrand Industry.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    266
  • Date
    2002-01-25
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    One hospital, a member of the ecri accident reporting system, reported loosening and peeling of the screw threads above all of these surgical foci in their inventory. the manufacturer states that these problems would not occur if the threads remain on these special screws. the hospital also reported paint chips in the balance of all these surgical foci, which probably resulted from contact with intravenous fluid bottle holders, shelves with monitors or other equipment. both problems could result in aggravations or contamination of sterile fields. hill-rom is currently contacting customers to see if other outbreaks are affected by the same issues.
  • Action
    Check in your inventory if you have any other surgical focus. Determine if the bolts are loose and / or if the paint is peeled. At the moment, Hill-Rom is working on a solution to fix both problems. For more information, or to inform the manufacturer of problems with outbreaks in your inventory, contact your local Hill-Rom representative or directly at 1 (812) 934-8189 in the USA. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. ECRI suggests using a locking wire and / or adhesive to hold the thread in place until Hill-Rom solves this problem. To minimize the risk of ink chipping, ECRI recommends that hospital staff be advised to avoid impact of the equipment with other metal brackets. Touch up or protect with adhesive any area containing peeling paint. If some threads are loose or missing in the foci of your inventory, or need paint for touch-ups, call the manufacturer to receive them. In addition, ECRI suggests positioning the focus elsewhere to reduce the chance of injury or contamination. Additional comment: One week after the publication of this Alert, Ecr i had a telephone conference with Hill-Rom, the company acknowledged this week's suggestions and announcements and requested that any affected customer contact Hill-Rom at mentioned above for information and

Device

Surgical Light Model P1350 Press Surgical Light. Distributed Units in US and Internationally

Manufacturer

Hill-Rom Co Inc A Hillenbrand Industry
  • Source
    ANVSANVISA