Events

Safety Alert for BARIATRIC REHABILITATION PLATFORM BEDS (BARIATRIC REHABILITATION PLATFORM BEDS

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

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
    140
  • Date
    2000-09-29
  • 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 two incidents in which the accession of the bariatric rehabilitation platform is released, causing injury to the nurse. the course of the launder was still under the nurse that has not being adjusting the equipment that holds handling.
  • Action
    MAKE SURE THAT TEAM MEMBERS ARE TRAINED ABOUT THE CORRECT USE OF THE BED SHEET MECHANISM. REPORT TO EMPLOYEES THAT HANDLING CAN FALL IF IT IS NOT TIGHT WELL. (2) MAKE SURE THAT EMPLOYEES ROTINALLY CHECK THE MECHANISM OF THE LAYOUT OF THE BED TO MAKE SURE THAT THE SAME IS SECURELY ADAPTED / TIGHTENED, AS WELL AS THE OTHER MECHANISMS OF THE BED. (3) ENSURE EMPLOYEES NOT TO DRIVE OR MOVE BRUSHLY AGAINST COURT BURNING TO PREVENT NON-INTENTIONAL LOOSENING. (4) IF THERE ARE ANY SUSPICIOUS PROBLEMS WITH THE BED, PLEASE CONTACT YOUR LOCAL DISTRIBUTOR OR DIRECTLY WITH WHEELCHAIRS OF KANSAS

Device

BARIATRIC REHABILITATION PLATFORM BEDS (BARIATRIC REHABILITATION PLATFORM BEDS

Manufacturer

WHEELCHAIRS OF KANSAS
  • Source
    ANVSANVISA