LIFEPAK 20/20e defibrillator/monitor 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2010/070

CON093820

2010-09-09

2010-09-09

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON093820?tabName=allTabs

Due to component failures, which affect ac (mains) and/or dc (battery) operating power, there is a risk that the defibrillator will not deliver therapy.The corrective action programme initiated by the manufacturer will take approximately two years to complete.Problem 1: no dc (battery) operating powercurrent leakage can prevent operation when using dc battery power.  failure of dc power can result in an inability to deliver defibrillation therapy, if no ac power is available. the global failure rate is 0.9% to date.Problem 2: no ac (mains) operating powera component failure prevents ac power operation and prevents battery charging capability. failure of ac power can result in an inability to deliver defibrillation therapy if dc power is depleted.The global failure rate is 0.7% to date.Solutionaffected devices may have problem 1, or problem 2, or both problems. the following phased corrective actions to replace the power supply board have been initiated: phase 1 dc power – identifies devices at a higher risk that accounts for 92% of all dc power failures. the manufacturer expects to complete this phase in 9 to 12 months. phase 2 ac power – identifies the remaining lower risk devices that will be updated upon completion of phase 1. the manufacturer expects phase 2 to take an additional 9-12 months to complete.

1. Assess the need for a back-up or alternative device whilst awaiting corrective action.2. All users should ensure that: they are aware of manufacturer’s Field Safety Notice. the manufacturer’s recommended daily inspection and testing as per the operator’s checklist are performed. where possible, devices are connected to AC mains power and the DC battery kept continuously on charge. 3. The manufacturer has contacted all affected customers. However, if you wish to check if your device is affected, refer to the Field Safety Notice. Be aware of the two year timeline for completion of the corrective action. Assess the need for a back-up or alternative device during this period. If your device exhibits either or both problems, report the failure of the device to the manufacturer and to the MHRA. Arrange for repair of the device with the manufacturer.