Events

Safety Alert for OXIMETER, PULSE. PHYSIOLOGICAL MONITORING SYSTEM, NEONATAL. PROBES, OXIMETER. . [] EQUIPMENT: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES PHYSIOLOGIC MONITORING SYSTEMS: (1) DASH 2000, (2) DASH 3000, (3) DASH 4000, (4) EAGLE, (5) SOLAR 8000, (6) SOLAR 8000M, ) TRAM 450SL; NELLCOR SPO2 PULSE OXIMETER SENSORS: (8) DISPOSABLE, (9) REUSABLE

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MONITORING DIV [393580], 8200 W TOWER AVE, MILWAUKEE WI 53223-3219; (8 E 9) MALLINCKRODT INC A TYCO HEALTHCARE GROUP CO [225956], PO BOX 5840, ST LOUIS MO 63134.

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
    97
  • Date
    2001-06-30
  • 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
    A member hospital of the ecri user network expressed the concern that during the monitoring of sp02 in which the ge medical systems information technologies (gems-it) physiological monitoring systems and the above pulse oximetric discharging sensor was used, a disconnection of the patient's sp02 sensor that could not be detected due to the lack of a persistent sound indicator to alert team members. the member hospital declares that, when disposable sensors are used, the monitoring system to which these are connected, indicates the disconnection through a single sound signaling on the side of the bed and on the central monitors, which is less unnelving that the repeating sounds when the sp02 reusable sensors are used. the member hospital declares that, after not being aware of any adverse episode, there is the concern that members of the team can not perceive if the disposable sensors leave the patient. ecri declares that an investigation revealed that this problem occurs with the eagle line monitors or when the multi parameter module or single spo2 parameter modules are used with the solar 8000 monitor. the manufacturer declares that the problem also affects the monitor solar 8000m and the dash monitor line.
  • Action
    REFER TO THE ORIGINAL REPORT BELOW UNDERSTANDING THE REASON BEHIND THE FOLLOWING RECOMMENDATIONS ECRI RECOMMENDS THE FOLLOWING: (1) NOTIFY THE USERS OF THE GEMS-IT MONITORS OF THE PROBLEM AND THE ECRI REPORT. (2) IF YOUR INSTITUTION USES NELLCOR SP02 DISPOSABLE SENSORS WITH SOLAR 8000M, DASH 3000 OR DASH 4000 MONITORS, GET A NEW GEMS-IT SOFTWARE / PROGRAM WHEN IT IS AVAILABLE (PROGRAM / SOFTWARE VERSIONS AND RELEASE DATES NOT DISCLOSED BY GEMS-IT); THE PROGRAM WILL PRODUCE AN AUDIBLE AND REPEATABLE ALARM FOR PULSE / PULSE SEARCH? (2) NO PROGRAM WILL BE AVAILABLE TO THE EAGLE MONITOR LINE, TO THE DASH 2000 MONITOR OR TO THE OLDEST MONITOR MODELS OF THE SOLAR 8000. (3) IF YOUR USE IS NOT USED OR UNABLE TO USE THE PROGRAM, EMPLOY THE REUTILIZABLE SENSOR UNTIL DISPOSABLE, WHEN POSSIBLE, AND, (3) MAKE SURE TO CONSIDER REGULATORY PATIENT TO MAKE SURE THAT THE SPO2 IS BEING MONITORED CORRECTLY. FOR FURTHER INFORMATION, PLEASE CONTACT RICH DIEFES, ECRI, TELEPHONE (610) 825-6000, RAMAL 5536

Device

OXIMETER, PULSE. PHYSIOLOGICAL MONITORING SYSTEM, NEONATAL. PROBES, OXIMETER. . [] EQUIPMENT: GE ...

Manufacturer

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MONITORING DIV [393580], 8200 W TOWER AVE, MILWAUKEE ...
  • Source
    ANVSANVISA