Events

Device Recall Philips Efficia 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Electronics North America Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    76274
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1229-2017
  • 사례 시작날짜
    2017-01-17
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152614
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • 원인
    The monitor may not alarm appropriately for a pediatric or neonatal patient.
  • 조치
    Philips sent each known affected customer an Urgent Medical Device Correction Notification/Field Safety Notice dated December 2016 to inform customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of providing a replacement MRx unit, free of charge, for all units affected by this issue. When the replacement unit arrives, please use the return shipping label and packaging provided with the replacement MRx unit to return the affected unit to Philips. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: Option A: For any neonatal or pediatric patient, if the bedside monitor (without CO2) is connected to CMS200, do not place the bedside monitor in Standby when the patient is transported to a procedure. This will allow the alarms limits to work properly. Contact your service provider to determine the settings of your system and change if necessary. Option B: For any neonatal or pediatric patient, if the bedside monitor (without CO2) connected to CMS200 is placed in Standby when the patient is transported to a procedure. When the same patient returns to unit and is placed back on monitor, take the following steps: If clinician need disable or change alarm limit at CMS200 side, he/she need to discharge this patient at CMS200 side first, and admit same patient ID again. (Reference: Instruction for Use, Document Number 4535 645 61281, Page 89 of 199, section: Discharging a patient) This will allow the alarms limits to work properly. Contact your service provider to determine the settings of your system and change if necessary. For questions regarding this recall call 978-659-3000.

Device

Device Recall Philips Efficia
  • 모델명 / 제조번호(시리얼번호)
    US11600058 US11600059 US11600060 US11600061 US11600062 US11600063 US21600064 US21600065 US21600066 US21600067 US21600068 US31600069 US31600071 US31600073 US31600074 US31600075 US31600077 US31600078 US31600079 US31600080 US31600081 US31600082 US41600084 US41600085 US41600086 US41600087 US41600088 US41600089 US41600090 US41600091 US41600092 US41600093 US41600094 US41600095 US41600096 US51600097 US51600098 US51600099 US51600100 US51600101 US51600102 US51600103 US51600105 US51600106 US51600107 US51600108 US51600109 US51600110 US51600111 US51600112 US51600113 US51600114 US61600115 US61600116 US61600117 US61600118 US61600119 US61600120 US61600121 US61600122 US61600123 US61600124 US61600125 US61600126 US61600129 US61600130 US61600131 US61600132 US61600133 US61600134 US61600135 US71600136 US71600137 US71600138 US71600139 US71600144 US71600145 US71600147 US71600148 US71600149 US71600150 US81600151 US81600152 US81600155 US81600156 US81600157 US81600158 US81600160 US81600161 US81600162 US81600163 US81600164 US91600165 US91600167 US91600171 US91600172 US91600173 US91600174 US91600175 US91600176 US91600177 USD1500045 USD1500046 USD1500047 USD1500048 USD1500049 USD1500050 USD1500051 USD1500052 USD1500054 USD1500056 USD1500057 USN1500002 USN1500003 USN1500004 USN1500005 USN1500006 USN1500007 USN1500008 USN1500009 USN1500010 USN1500011 USN1500015 USN1500016 USN1500017 USN1500018 USN1500019 USN1500028 USN1500029 USN1500030 USN1500031 USN1500032 USN1500034 USN1500035 USN1500036 USN1500037 USN1500038 USN1500039 USN1500040 USN1500041 USN1500042 USN1500043 USN1500044 USO1600182 USO1600183 USO1600184 USO1600185 USO1600186 USO1600187 USO1600188 USO1600189 USO1600190 USO1600191 USO1600192 USO1600193 USO1600196
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution including Austria Bangladesh Bulgaria Chile France Germany Hong Kong India Ireland Israel Italy Korea, Republic of Malaysia Myanmar Philippines Poland Portugal Saudi Arabia Thailand Turkey United Arab Emirates United Kingdom United Republic of Tanzania
  • 제품 설명
    Philips Efficia CMS200 Central Monitoring System; 863352 || The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and vital signs monitors) for multiple patients. It provides secondary operator notification of alarms from other networked medical devices. It provides for the retrospective review of alarm conditions, physiologic waves and parameters from multiple patients. The intended use of the printer, when present, is to provide hardcopy text, graphics, and wave data. The Efficia CMS200 may provide for connection and information exchange to external systems. The Efficia CMS200 is intended for use in hospitals and out of hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is administered by healthcare professionals
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • 제조사 주소
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA