Events

Device Recall Fabius GS Premium 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Draeger Medical, 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
    80209
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2250-2018
  • 사례 시작날짜
    2018-05-24
  • 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=164868
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • 원인
    The draeger anesthesia device may be able to dose 100% n2o. in the event of a fault, the s-orc module would not prevent setting an n2o flow that would result in a hypoxic mixture from being dosed to the patient. potential adverse outcomes include death of the patient.
  • 조치
    On May 24, 2018, the firm issued Urgent Medical Device Recall letters to affected end users (medical facilities) via certified mail. The letter identified the affected product, problem and actions to be taken. The recalling firm stated that they are currently manufacturing replacement parts for all potentially affected devices, which will be installed as part of the next service. The firm's Service dept. will contact end users to arrange the replacement Free of Charge In addition, end users were asked to complete and return a Customer Reply Card to acknowledge the receipt of this information. If you have any questions regarding this recall please contact Michael Kelhart between the hours of 8:00 AM  4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349). For questions regarding the operation and/or servicing of your Draeger anesthesia machine please contact DraegerService Technical Support between the hours of 8:00 AM  8:00 PM EST at 1-800-437-2437 (press 4 at the prompt then 4 again).

Device

Device Recall Fabius GS Premium
  • 모델명 / 제조번호(시리얼번호)
    ASKM-0102 ASKM-0220 ASKM-0103 ASKM-0221 ASKM-0124 ASKM-0222 ASKM-0125 ASKM-0223 ASKM-0129 ASKM-0224 ASKM-0132 ASKM-0229 ASKM-0133 ASKN-0061 ASKM-0134 ASKN-0090 ASKM-0135 ASLA-0035 ASKM-0136 ASLA-0046 ASKM-0137 ASLA-0047 ASKM-0138 ASLA-0048 ASKM-0139 ASLA-0049 ASKM-0189 ASLA-0050 ASKM-0190 ASLA-0053 ASKM-0191 ASLA-0070 ASKM-0192 ASLA-0071 ASKM-0193 ASLA-0072 ASKM-0194 ASLA-0073 ASKM-0195 ASLA-0074 ASKM-0198 ASLA-0075 ASKM-0199 ASLA-0129 ASKM-0200 ASLA-0131 ASKM-0201 ASLA-0133 ASKM-0202 ASLA-0140 ASKM-0204 ASLA-0141 ASKM-0205 ASLA-0159 ASKM-0207 ASLA-0199 ASKM-0208 ASLA-0200 ASKM-0215 ASLA-0201 ASKM-0219 ASLA-0218
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution - Healthcare facilities in AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MD, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, WA, WI, and WV.
  • 제품 설명
    Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 || Product Usage: || Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). As per IEC 60601-2-13 (Anesthetic Workstations and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and anesthetic agent is required when the machine is in use. IEC 60601-2-13:2003 requires that a manual ventilation bag must be available for emergency use. Fresh gas enrichment is provided by the Dr¿ger Vapor anesthetic vaporizer. Fabius MRI can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • 제조사 주소
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • 제조사 모회사 (2017)
    Stefan Dräger GmbH
  • Source
    USFDA