Events

Safety Alert for Ultrasound equipment for EPIQ diagnosis, EPIQ models 5 and 7. Registration: 10216710275. Class III. Products Affected: EPIQ 7 - Version 1.3.2 or lower with Pediatric Cardiology option. EPIQ 5-US814C0626 / US914C0627 / US914C0261 / USO14C0601 / USO14C0602 / USO14C0603 / USO14C0604 / USO14C0605 / USO14C0606 / US215C0175 / US215C0429 / US215C0430 / US215C0432 / US215C0432 / US215C0434 / US215C0434

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

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
    1576
  • Date
    2015-05-08
  • 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
    The conclusion of the risk analysis performed by the company was not acceptable for pediatric cardiology and acceptable for the rest of the applications. If a health care provider makes a clinical decision based on a calculated Cardiac Index using an incorrect BSA without considering other indicators of cardiac function, the result may be an incorrect diagnosis and / or delayed or incorrect therapy.
  • Reason
    When the epiq 5 and 7 ultrasound system is set to "metric" and the weight and / or height are reported, a unit conversion error may result in incorrect calculation of the body surface area (bsa) of the patient. when using only the patient's weight to calculate bsa, which is standard practice for patients below 2 years, the result would bring a very high value, by a factor of approximately 1.7. the cardiac index calculated using this value would be very low, by a factor of 1.7. an error of this magnitude may not be immediately detected by the user.
  • Action
    The registry holder will perform a field correction of the equipment and advises users to verify that the version of the software used is affected. If you have an affected software version and the Pediatric option is enabled, contact your local Philips representative to schedule an update of your software. ////// Until your software can be updated, the situation can be avoided by ensuring that the "Patient Data Units" setting is set to "English" units. If this setting is not acceptable to your institution and you need to use the Metric units, you can avoid the problem by ensuring the following: 1. After turning on the system, open the Patient Data screen once before including a scan. This will put the Patient Data screen back in an appropriate status and the problem will not occur. 2. Ensure that the Patient Data screen is maintained on the Metric units instead of enabling the English units. If a height or weight value has to be reported in English units, then it must be converted to Metric manually to avoid the problem. Finally, ensuring that the Patient Data screen is using the Metric units before uploading the data of any examination will prevent the data from this examination from being changed.

Device

Ultrasound equipment for EPIQ diagnosis, EPIQ models 5 and 7. Registration: 10216710275. Class II...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA