Events

Safety Alert for CHILDREN'S INCUBATORS C2HS ISOLETTE

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by HILL ROM AIR-SHIELDS A HILLEBRAND CO..

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
    26
  • Date
    2001-05-14
  • 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
    BRAZIL - COMPANY INSTRUCOM informs that the corrections have been implemented in the manufacturing line, therefore the product presents no risk to the patient or to the user.
  • Reason
    White layers of waste in the humidity evaporator reservoir were reported with these incubators. in a report, the waste occurs the tube that connects the camera to the reservoir. this problem persisted even after the sterile water is replaced by ag.
  • Action
    IDENTIFY ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. REPORT USERS AND MAINTENANCE MANAGERS IN THEIR ALERT SETTING. THE MANUFACTURER AFFIRMS THAT THE RESERVOIR HAS BEEN MODIFIED BY PLACING A FLUORATED POLYMER COATING LAYER, SEALING, ON THE RESERVOIR ALUMINUM SURFACE TO PREVENT CORROSION AND AVOID WASTE FORMATION. THE MODIFIED RESERVOIR IS INCORPORATED IN ALL UNITS PRODUCED AS OF APRIL 21, 2000 AND IS AVAILABLE TO REPLACE IN UNITS WHICH NEED, HAVE RESIDUES, OR ARE NOT OPERATING. ECRI RECOMMENDS THE FOLLOWING: (1) NOTIFY YOUR PERSONNEL TO OBSERVE THAT WASTE AND WILL ALERT THESE POSSIBILITIES. REMEMBER ONLY WHAT DISTILLED WATER SHOULD BE USED. (2) IF DISTILLED WATER IS ONLY USED BUT WASTE WASTE TANKS, CONTACT THE MANUFACTURER TO REPLACE THE RESERVOIR [TELEPHONE: 0021-1-215-675-5200]. (3) EXAMINE THE CONDITION OF THE TUBES. PLEASE NOTE AND ALERT THAT THIS TUBE VERIFICATION MUST BE PART OF THE INSPECTION PROGRAM AND PREVENTIVE MAINTENANCE FOR EVERY 6 MONTHS.

Device

CHILDREN'S INCUBATORS C2HS ISOLETTE

Manufacturer

HILL ROM AIR-SHIELDS A HILLEBRAND CO.
  • Source
    ANVSANVISA