Events

Safety Alert for Surgical Light Model P1350 Press Surgical Light. Distributed Units in US and Internationally

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Hill-Rom Co Inc A Hillenbrand Industry.

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
    266
  • 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
    One hospital, a member of the ecri accident reporting system, reported loosening and peeling of the screw threads above all of these surgical foci in their inventory. the manufacturer states that these problems would not occur if the threads remain on these special screws. the hospital also reported paint chips in the balance of all these surgical foci, which probably resulted from contact with intravenous fluid bottle holders, shelves with monitors or other equipment. both problems could result in aggravations or contamination of sterile fields. hill-rom is currently contacting customers to see if other outbreaks are affected by the same issues.
  • Action
    Check in your inventory if you have any other surgical focus. Determine if the bolts are loose and / or if the paint is peeled. At the moment, Hill-Rom is working on a solution to fix both problems. For more information, or to inform the manufacturer of problems with outbreaks in your inventory, contact your local Hill-Rom representative or directly at 1 (812) 934-8189 in the USA. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. ECRI suggests using a locking wire and / or adhesive to hold the thread in place until Hill-Rom solves this problem. To minimize the risk of ink chipping, ECRI recommends that hospital staff be advised to avoid impact of the equipment with other metal brackets. Touch up or protect with adhesive any area containing peeling paint. If some threads are loose or missing in the foci of your inventory, or need paint for touch-ups, call the manufacturer to receive them. In addition, ECRI suggests positioning the focus elsewhere to reduce the chance of injury or contamination. Additional comment: One week after the publication of this Alert, Ecr i had a telephone conference with Hill-Rom, the company acknowledged this week's suggestions and announcements and requested that any affected customer contact Hill-Rom at mentioned above for information and

Device

Surgical Light Model P1350 Press Surgical Light. Distributed Units in US and Internationally

Manufacturer

Hill-Rom Co Inc A Hillenbrand Industry
  • Source
    ANVSANVISA