Events

Device Recall Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Draegar Medical Systems, Inc. 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
    79871
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1813-2018
  • 사례 시작날짜
    2018-03-28
  • 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=163782
  • 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
    Software anomaly resulting in the loss of patient settings and stored patient data.
  • 조치
    On March 28, 2018, Drager Medical Systems Inc. mailed Urgent Medical Device Recall Notifications to affected customers. The following information was included in the notification: 1) Do not use Infinity MCable Mainstream CO2 sensors revision 16 with M540 Patient Monitor, software versions VG4.1 or lower. Previous revisions of the CO2 sensor may be used. 2) We are in process of resolving this product issue. If you choose to upgrade your system(s), your Dr¿ger service representative will schedule a service visit and upgrade your M540 patient monitor(s) once the updated software is available for distribution. 3)A Customer Reply Card will be included as a receipt from the customers that they received this information and to indicate if the customer would like the revised software update once it is available. Customer with questions regarding the notification may call (800) 437-2437 (press 1 at the prompt, then 32349) Customers with questions regarding the operation and/or servicing of the Drager Infinity Acute Care System may contact Drager Service Technical Support at (800) 437-2437 (press 4 at the prompt then 4 again).

Device

Device Recall Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms)
  • 모델명 / 제조번호(시리얼번호)
    Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818  UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and to the countries of : Angola, Argentina, Australia Austria Azerbaijan Bahrain Belgium Bolivia Brazil Brunei Dar-es-S Canada Chile China Colombia Costa Rica Czech Republic Denmark Egypt Finland France Germany Ghana Greece Hong Kong Hungary India Indonesia Ireland Italy Japan Jordan Kenya Kuwait Latvia Liechtenstein Lithuania Macedonia Malaysia Maldives Mexico Monaco Mozambique Namibia Netherlands New Zealand Norway Pakistan Panama Peru Poland Portugal Qatar Reunion Russian Fed. Saudi Arabia Singapore Slovenia South Africa South Korea Spain Sweden Switzerland Thailand Trinidad &Tobago; Turkey Turkmenistan United Kingdom USA Utd.Arab.Emir. Vietnam
  • 제품 설명
    Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, || 4049098009799, 4049098009751. || Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time.
  • Manufacturer
    Draegar Medical Systems, Inc.

Manufacturer

Draegar Medical Systems, Inc.
  • 제조사 주소
    Draegar Medical Systems, Inc., 6 Tech Dr, Andover MA 01810-2434
  • 제조사 모회사 (2017)
    Stefan Dräger GmbH
  • Source
    USFDA