Events

Safety Alert for Trademark: IntelliVue iX Information Center. Technical Name: Software. Registration number ANVISA: 10216710250. Risk class: III. Affected Model: M3290B .. Number of Series Affected: 5750-5JHY-H; 087W-4VK7-W; 6W4K-0GN9-A; 453E-1AHM-H; 7216-59N8-6; 7R0L-6AMX-B; 5G75-5WKF-8; 745P-55J9-R; 3H1F-42GL-N; 0R3L-5PP3-T; 3N4R-43JR-A; 2N H-7HN-N; 5W0N-4FL0-2; 5K15-0MNA-D; 005J-0ZNF-1; 5636-61K2-R; 4V6P-2XHV-X; 2A1H-7HJU-U; 312C-5MGJ-2; 2C49-12JD-P; 5F5Y-11KG-C; 7B7G-2UGW-5; 7J34-24GX-T; 2W76-3ZKP-P; 597Y-7BG9-Y; 1W5W-66H9-W; 2E4R-43JR-3; 7V5H-1YML-2; 204 D-2HJF-P; 412W-1VNP-R; 0K52-6KKD-7; 6A78-1LMN-3; 6F2P-1RHT-T; 0T6R-3KLU-9; 080V-7AHH-6; 6W33-5BNT-X

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Philips Medical Systems Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2464
  • Date
    2017-01-09
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    To avoid this problem, do not intentionally restart any surveillance station that has been operating normally since the new year. You can use the workflows in the Annex "Alternate Workflows for PIIC IX" to avoid operations that may lead to the resumption of the surveillance station. When a patient is discharged, confirm that the patient has been discharged. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Vigilance should be made through System NOTIVISA. To access the System, you must register and select the Health Professional option, if you are a professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 09/01/2018 - Date of notification notice to Anvisa: 03/01/2018 The company holding the registration of the affected product is responsible for contacting, in a timely manner , its clients in order to guarantee the effectiveness of the ongoing Field Action. The solid responsibility of the distribution chain and use of the products for health in the maintenance of its quality, safety and efficacy, as well as of the effectiveness of the Field Action, expressed by RDC 23/2012 : "(...) Art. 2" A holder of registration of product for the health of the holder of the registration / registration of product for the health together with Anvisa. Single particle. The registration holder, as well as the other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the products for sa To the end consumer. Art. 12 Distributors of health products shall forward to the holder of registration, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) ¡±
  • Reason
    The issue affects all piic ix surveillance and patient link ix revisions. this problem will occur after the surveillance station is reinitialized for the first time during the year 2018. after such initial re-initialization, the station will no longer perform the transfer and discharge operations of the patient . if an attempt is made to perform any of the following transfer or discharge operations, the operation will not be completed, and instead the surveillance station will be reset: • discharge a patient under certain conditions; • transfer a patient (from the edge of the bed or central station); • solve patient conflicts (from the edge of the bed or central station) where the bedside patient should overlap the piic ix patient (revision b.0x and c.0x only); • unclogging a surveillance sector; • assigning a bed to an empty surveillance area. the surveillance station will continue to monitor patients after any reset.
  • Action
    Field Action Code FCO86201814 triggered under the responsibility of the company Philips Medical Systems Ltda. Far¨ Correction in field

Device

Trademark: IntelliVue iX Information Center. Technical Name: Software. Registration number ANVISA...

Manufacturer

Philips Medical Systems Ltda.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA