Events

Safety Alert for Fetal Monitor Corometrics 170, Models 171, 172, 173, 174, Hazard Class II, Record: 80071260210, with serial numbers in the following range :. SAS12048362PA to SAS15114103PAS.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE Healthcare do Brasil; WIPRO GE HEALTHCARE PVT. LTD..

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
    1584
  • Date
    2015-05-13
  • 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
    According to record holder data, if the Lower Fetal Heart Rate (FHR) alarm threshold setting is not performed correctly, the equipment will only issue the alarm when the FHR value is below 50 BPM (appropriate setting: 120 BPM ). Incorrect configuring at 50 BPM may lead to delays in clinical practitioner responses and adverse events such as fetal bradycardia and oxygen deprivation if the clinical staff does not perceive the FHR value reduction alert. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.
  • Reason
    According to information from the registry holder the monitors were delivered with the lower limit of the fetal heart rate (cfc) alarm configured incorrectly at 50bpm, being the standard 120bpm.
  • Action
    The company will perform a field correction with the sending of an urgent security warning letter, with instructions to the user for the detection of the affected units, and reconfiguration of the lower limit of the Fetal Card Frequency alarm. You should: 1. Review your facility's monitors to determine if any affected products are in use (serial number in the range SAS12048362PA through SAS15114103PAS). * If any monitor is affected, the user must follow the steps below: 2. Check the current values ​​of the lower alarm limit for each affected system. If the limit is set to an appropriate setting, the monitor may continue to be used. Note: The value of the lower limit of the FCF alarm can be verified by any of the following two methods: a. Printing on the tape chart during startup and every 10 minutes when alarms are enabled OR b. The current value of the FCF is shown in the user setup mode (UserSetup) on the monitor screen - see Appendix 1 of the Urgent Security Notice Letter attached to this form for more details. * 3. If the displays are not configured at the required levels or at the default level of 120 BPM, set them to 120 BPM or a level that best meets your needs by following the instructions in Appendix 1 of the Urgent Security Notice Letter attached to this form. Note the serial number of each product checked on the Medical Device Correction Confirmation form (see Appendix 2 of the Safety Notice Letter), and fill in the remaining items on the form. The form must be sent to GE Healthcare within 2 weeks of receipt of this letter. The instructions for submitting the form to GE are contained in it. /////// After the correction, the client should send a correction confirmation form. GE will visit customers who do not submit the correction confirmation form. SEE ATTACHED

Device

Fetal Monitor Corometrics 170, Models 171, 172, 173, 174, Hazard Class II, Record: 80071260210, w...

Manufacturer

GE Healthcare do Brasil; WIPRO GE HEALTHCARE PVT. LTD.