Events

Safety Alert for Product name: Defibrillator / Monitor Technical Name: DEFIBRILLATOR / MONITOR ANVISA Registration Number: 80102511541 Hazard Class: III Model Affected: LIFEPAK 15 Serial Numbers Affected: 44574467; 44574771 and 44574821.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VR MEDICAL LTDA; PHYSIO-CONTROL, 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
    2173
  • Date
    2017-02-07
  • 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
    User Testing The User Test is a functional test of the LIFEPAK 15 monitor / defibrillator. User Testing should be performed only for the purpose of testing, not while using the defibrillator for patient care. Run the User Test as a part of the Operator's Daily Checklist. Note: The defibrillator must be in Manual mode to run the User Test. To run the User Test outside of the Operator Checklist: 1. Press ON to turn on the LIFEPAK 15 monitor / defibrillator. 2. Press OPTIONS. The Options menu is displayed. 3. Select USER TEST. The defibrillator performs the following tasks: • Self-test to check the device: • Charges to 10 joules and discharges internally (this power can not be accessed in the therapy connector.) • Prints an approval / failure report. If the LIFEPAK 15 monitor / defibrillator detects a fault during the User Test, the Service LED turns on and the printed report indicates that the test failed. Remove the use defibrillator and contact a qualified service technician. If you need to stop the User Test, turn the device off and then on again. The test is interrupted and the defibrillator operates normally. The approval / failure report does not print.
  • Reason
    Physio-control has become aware of a potential problem in the device that may make it impossible for the lifepak device 15 to provide energy for defibrillation due to the possible failure of an internal (relay) component installed in the therapy printed circuit board assembly (pcba, the detection of the problem was based on a (01) complaint received outside brazil where an equipment failed the user's daily test (instructed by the service manual). the device displayed "abnormal energy delivery" and logged error code a51e. the relay defect can be identified during the device user test, as described in the chapter titled "equipment maintenance" in the lifepak 15 operating instructions (see the excerpt of the operating instructions on page 2 of this notice).
  • Action
    Field Action Code AC003-17 triggered under the responsibility of the company VR MEDICAL LTDA. Company will test user for later field correction if necessary.

Device

Product name: Defibrillator / Monitor Technical Name: DEFIBRILLATOR / MONITOR ANVISA Registration...

Manufacturer

VR MEDICAL LTDA; PHYSIO-CONTROL, INC.
  • Source
    ANVSANVISA