micro-pace 4580 의 안전성 경고

Safety alert

2012-09-25

2012-09-25

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120925a.html

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.