Events

Safety Alert for micro-pace 4580

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Pace Medical.

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
  • Date
    2012-09-25
  • Event Date Posted
    2012-09-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120925a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: pace medical micro-pace 4580 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning micro-pace 4580, manufactured by pace medical, inc. pace medical has observed in the ref 4580 that in a specific use of the device the defibrillation protection circuitry may not function as well as intended. if the device is used on a patient, with heart wires and the patient’s heart is defibrillated directly on the heart, there may be a chance that the device will be damaged from the defibrillation output current. the manufacturer has designed and validated a new defibrillation protection circuit which will eliminate the potential for this to occur. furthermore, it advised that: users should return the affected device for a complimentary upgrade. the device should not be used in cardiac surgical theaters where heart wires are used and defibrillation is applied directly to the heart tissue. ref 4580 can be used in other procedures while scheduling product return, but patients should be monitored while the device is in use and a backup device should be on hand. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con185136 if you are in possession of the product, please contact your supplier for necessary actions. posted on 25 september 2012.

Device

micro-pace 4580
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Pace Medical MICRO-PACE 4580
  • Manufacturer
    Pace Medical

Manufacturer

Pace Medical