Events

Alerte De Sécurité sur IMPULSE SYSTEM OF PUMPS WITH PEDAL, MODEL 6060 KENDALL AV; WE. SERIES BELOW 72299, UNITS WITH CIRCUIT BOARD MARKED V2

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 ORTHOFIX CO. INGLATERRA.

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
    73
  • Date
    2001-05-18
  • 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 of the ecri member hospitals reported have found problems with these pumps with pedal, which had stopped to pump and was rebounded for standby mode, and recovered the pressure parameters in the low every vazque that the surgery acted the electrocirutric unit in the proximity, during an orthopedic surgery. the hospital also verified that the unit worked normally when it was away from the electrocirutric unit.
  • Action
    IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. KENDALL AFFIRMS THAT UPDATE V3, WHICH REPLACES V2 PLATE (PCB), HAS HIGHER PROTECTION AGAINST ELECTROMAGNETIC INTERFERENCE OF ELECTROCIRUTIVE UNITS. KENDALL RECOMMENDS THAT YOU WILL LEAVE THESE PRODUCTS WITH A V2 PLATE AT LEAST 1 METER DISTANCE FROM THE ELECTROCOURGICAL UNITS OR CONTACT KENDALL TO OBTAIN THE UPDATE SET THROUGH THE MAIL (ADDRESS: THE KENDALL CO, 15 HAMPSHIRE ST, PO BOX 9112, MANSFIELD MA 02048-9932, USA), BY FAX 0021-1-508-261-8582 OR BY PHONE 0021-1-508-261-6000. ECRI RECOMMENDS THAT (1) CHECK THE SERIAL NUMBERS, IF BELOW 72299, AND IF THIS PUMP WILL BE USED IN A SURGICAL BLOCK, CONTACT KENDALL TO OBTAIN UPDATE. (2) COLE, IN ANTIQUE PUMPS, WELL VISITED, THE LABEL IS THIS PUMP CAN NOT BE USED ON A SURGICAL BLOCK!

Device

IMPULSE SYSTEM OF PUMPS WITH PEDAL, MODEL 6060 KENDALL AV; WE. SERIES BELOW 72299, UNITS WITH CIR...

Manufacturer

ORTHOFIX CO. INGLATERRA
  • Source
    ANVSANVISA