Events

Alerte De Sécurité sur Integris Monitor Arms

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
    365
  • Date
    2002-01-16
  • 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
    The brackets of this monitor are associated with 03 potential risks: (1) when the arm mounting pins loosen, the monitor may fall off the arm. this risk can occur when the professional tries to move the monitor horizontally or vertically. (2) mechanical failure of the arm mounting inner knee may cause the monitor to fall when it comes from the lower position to the rest position. this risk can occur when the professional tries to turn the arm vertically. (3) if the mounting was improperly installed the monitor may fall from the stand. this risk can occur when the professional tries to move the monitor horizontally or vertically. any of these problems can cause injury to the patient or operator or damage to the monitor and the arm of the patient. the manufacturer initiated a correction by an urgent health product correction letter dated december 4, 2001.
  • Action
    Make sure you received the Health Product Urgent Correction letter dated December 4, 2001 and the 0.20-inch-inch pin-gauge pin from Hill-Rom. The manufacturer requires you to discontinue use of any monitor arm in your inventory until Hill-Rom's employee / inspector staff inspects and verifies that the unit is properly mounted. If it is essential to continue using the product Hill-Rom recommends that you notify the practitioner of the potential hazards described above, position the monitor as far as possible from the area where the patient will be and perform the inspection of the monitor arm. To inspect the monitor arm use the pin to check for clearance between the bottom of the base and the rotating adapter. If the pin comes fully into either side of the swivel adapter, remove the monitor arm from its service immediately. The manufacturer requests that you send the copy of the Urgent Correction of Health Products letter to all relevant personnel. In theory, you should have already been contacted by Hill-Rom regarding this correction. If this did not happen or you need more information, contact your local representative.

Device

Integris Monitor Arms

Manufacturer

Hill-Rom Co Inc A Hillenbrand Industry
  • Source
    ANVSANVISA