Events

Safety Alert for Affiniti Ultrasound System, Affiniti 50 and 70 models, hazard class II, registration: 10216710306. Serial numbers of affected products: US215D0998 / US215D0997 / US215F0871 / US215F0870.

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 Ultrasound, Inc..

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
    1602
  • Date
    2015-05-22
  • 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
    According to the record holder's information, using height and weight to calculate the BSA, which is a standard practice for patients over 2 years of age, the result may be very high by a factor of approximately 10, that is, the user could immediately identify this error. If a health care provider makes a clinical decision based on a Cardiac Index calculated 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
    According to the record holder, there is a unit conversion error in the metric setting for weight and height that can result in incorrect calculation of the body surface area. all of the following events must occur to create a hazardous situation: - system-wide drives are set to "metric" in the setups; - the patient data screen is open, the patient's name, weight and / or height have been entered, the patient data screen is closed; - an image is captured, the examination is terminated; - the system is restarted and the patient directory is opened (but not the patient data screen, or the problem will not occur), - the original examination is included (it does not matter whether through the option "add" or "create". /// when this happens, the system incorrectly converts metric height / weight values ​​to english while still retaining the metric units identification. the displayed height / weight values ​​are incorrect in the report, and the bsa (body surface area) calculation, which depends on height / weight, will be incorrect.
  • Action
    Philips will do a field correction of the problem by updating the software. You can confirm that your system has been affected by verifying the software version. Philips has corrected this problem in versions 1.0.3 and higher. If you have a software version affected, contact your local representative to schedule your upgrade. ///// Recommendation: 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 before including an examination. 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 in the Metric units instead of English units. If a height or weight value has to be reported in English [English] units, then it must be converted to Metric manually to avoid the problem. Finally, ensure that the Patient Data screen is using the Metric units before loading any survey data. This will prevent your data from being altered.

Device

Affiniti Ultrasound System, Affiniti 50 and 70 models, hazard class II, registration: 10216710306...

Manufacturer

Philips Medical Systems Ltda.; Philips Ultrasound, Inc.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA