Events

Safety Alert for Oximetric probe. Pulse Oximetry Sensor, Disposable

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

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
    275
  • Date
    2002-01-25
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    An ecri member hospital reported a case in which the patient had a skin lesion caused by a disposable oximetry sensor. a large section of the insulation that is normally placed on the led, light emitting diode, part of the sensor, has been ripped or plucked off, causing contact of the sensor electrical connection with the patient's skin. investigations of ecri regarding this incident revealed that the burn was more electrochemical than thermal, and was caused by a low voltage (voltage), direct electrolyte current in the tissue, which occurred in the exposed location with the electrical connection.
  • Action
    Electrochemical burns from the Pulse Oximetry Sensor can be prevented by not exposing the damaged electrical connection of the sensor to contact with the patient's skin. ECRI recommends the following to prevent the occurrence of such burns: (1) Alert the hospital staff of this problem and our alerts. (2) Ensure that the clinical protocol includes a check of the integrity of all pulse oximetry sensors (both disposable and reusable) before they are placed in the patient and when they are removed to a new location. Especially, inspect the sensor and sensor cable for cracks and cracks in insulation, electrical connection or wiring, and for any other damage. Only reuse the disposable sensor in the same patient according to the directions of use of the sensor supplier. (3) Instruct the staff to follow the provider's instructions when checking the integrity of the skin lying under the sensor and when changing the sensor location. By doing this, it will certainly help, prevent any injury, or if it occurs, to be treated immediately. (4) Inform personnel not to use damaged sensors or cables. The damaged sensor or cable must be clearly labeled "damaged" and sent to clinical engineering for evaluation and tracking of occurrences associated with health products. Notify ANVISA through the Notification Form associated with Health Products, available on the Internet www.anvisa.gov.br/tecnovigilância or by e-mail tecnovigilancia@anvisa.gov.br, or by fax 0xx61-4481257

Device

Oximetric probe. Pulse Oximetry Sensor, Disposable
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA