LifeVest 4000 Wearable Cardioverter Defibrillator 의 안전성 경고

Safety alert

2018-01-18

2018-01-18

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180118.html

Medical device safety alert: zoll lifevest 4000 wearable cardioverter defibrillator the food and drugs administration (fda), united states posted a medical device safety alert concerning lifevest 4000 wearable cardioverter defibrillator, manufactured by zoll. fda is providing information and recommendations regarding the zoll lifevest 4000 due to concerns that the device may fail to deliver treatment to the patient if the device is not replaced soon after displaying "call for service: device has a problem that may require service. call zoll for service, message code 102." ideally, the lifevest monitors the patient's heart, delivering a "treatment shock" as needed to restore the patient's heartbeat to a normal rhythm. however, fda is aware that in certain cases the lifevest 4000 may not be able to deliver a life-saving treatment shock to a patient due to a fault that prevents the device from charging its high-energy capacitors. during normal operation, this fault prompts the lifevest to display "call for service: device has a problem that may require service. call zoll for service, message code 102" on the device screen. the "message code 102" alert does not explicitly indicate to the patient that the device cannot be used and that the patient should call the manufacturer immediately. fda is aware of one patient death due to the lifevest's failure to deliver treatment as expected after message code 102 was displayed. according to the manufacturer, about 0.1% of the total devices distributed have displayed message code 102, which should only be remedied by immediate replacement of the device. the fda has provided recommendations for healthcare providers, patients and caregivers. for details, please visit the following fda website: https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm592710.Htm https://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ucm592583.Htm if you are in possession of the product, please contact your supplier for necessary actions. posted on 18 january 2018.