Events

Safety Alert for (1) IMAGE SCANNING SYSTEMS BY MAGNETIC RESONANCE. (2) INTRAVENOUS POLES. (3) HOSPITAL GAS CYLINDERS. (4) MACAS. (5) WHEELCHAIRS

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
    113
  • Date
    2001-07-01
  • 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
    XX
  • Reason
    Physicians of the westchester medical center in valhalla, ny reported an incident where a six year old boy that was being submitted to a magnetic resonance was fately reached in the head with an o2 tank which was magnized and closed in the examination room. this was not an isolated incident; other accidents have already happened in which metal objects are put to the next area of the magnetic resonance units.
  • Action
    ECRI RECOMMENDS THE FOLLOWING FOR THE PREVENTION OF INDUCED MAGNETIC FIELD RELATED RISKS IN A MAGNETIC RESONANCE UNIT ENVIRONMENT: (1) INDICATE A SECURITY OFFICER IN THE MAGNETIC RESONANCE UNIT (URM) WHO WILL BE RESPONSIBLE FOR MAKING THAT THE MEASURES SAFETY INSTRUCTIONS. (2) IDENTIFY AREAS IN THE URM AND ROOMS NEARBY (INCLUDING THOSE ON ADJACENT FLOORS) WHERE THE MAGNETIC FIELD STRENGTH EXCEEDS 5G, AND LIMIT THE ACCESS TO THESE AREAS. (3) ALWAYS AWAY THAT THE STATIC OF THE MAGNETIC FIELD BE PRESENT AND TREAT THE SYSTEM PROPERLY. (4) DOES NOT ALLOW URM, EQUIPMENT OR EQUIPMENT THAT CONTAIN MAGNETIC (MAINLY FERROMAGNETIC) COMPONENTS ABOVE THE 5G LINE UNLESS THEY HAVE BEEN TESTED BY THE EQUIPMENT MANUFACTURER AND HAVE BEEN CONSIDERED SAFE FOR URM ENVIRONMENTAL USE. TAKE ANY RESTRICTIONS MENTIONED BY THE MANUFACTURER IN CONNECTION WITH THE USE OF EQUIPMENT SAFE AND COMPATIBLE WITH URM. (5) TEST ALL EQUIPMENTS THAT ARE IN THE ENVIRONMENT OF THE MAGNETIC RESONANCE UNIT WITH A POWERFUL MAGNETO BEFORE THEY ENTER THE AREA TO DETERMINE THEIR POTENTIAL OF ATTRACTION BY THE URM. (6) IF EQUIPMENT CONTAINING FERROMAGNETIC COMPONENTS MUST BE USED IN A URM ENVIRONMENT, CONSIDER THE FOLLOWING GUIDELINES: (A) PHYSICALLY FIX EQUIPMENT USING NON-MAGNETIC MEDIA (EG, NON-MAGNETIC NUTS, ROPE, PLASTIC CURRENTS, WEIGHT, VELCRO FIXERS) AT A MAGNETO DISTANCE (AS SPECIFIED BY THE MANUFACTURER), AND ADEQUATELY LABELED TO PREVENT THAT THE SAME IS PLACED VERY NEAR THE URM SYSTEM. IT IS IMPORTANT THAT THE PROPOSED METHOD FOR FIXING THE EQUIPMENT BE PROPERLY TESTED BEFORE ITS USE. (B) MAKE SURE THAT ALL SMALL COMPONENTS OF FERROMAGNETIC EQUIPMENT, SUCH AS COVERS AND COVERS ARE FIRMLY CLOSED TO THE EQUIPMENT (BY NON-MAGNETIC MEANS); ALONG THE TIME THE FERROMAGNETIC COMPONENTS CAN RELEASE. (7) BRING PATIENTS THAT ARE NOT AMBULATING THE URM ENVIRONMENT, USING WHEEL CHAIRS OR NON-MAGNETIC SOAPS. MAKE SURE THAT NO O2 BOTTLE IS HIDDEN UNDER THE LENGHT. (8) MAKE SURE THAT THE INTRAVENOUS POLES ACCOMPANYING THE PATIENT TO URM BE COMPATIBLE WITH THE ENVIRONMENT

Device

(1) IMAGE SCANNING SYSTEMS BY MAGNETIC RESONANCE. (2) INTRAVENOUS POLES. (3) HOSPITAL GAS CYLINDE...
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA