Events

Device Recall Propaq LT 802LT series Vital Signs Monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Welch Allyn Protocol, 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
    66919
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0633-2014
  • 사례 시작날짜
    2013-11-21
  • 사례 출판 날짜
    2014-01-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-02-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124195
  • 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 (Without Arrhythmia Detection Or Alarms) - Product Code MWI
  • 원인
    Welch allyn will update propaq 802 series vital signs monitor, models are 802ltan, 802lton and 802ltr with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations.
  • 조치
    Welch Allyn began sending out the Urgent Medical Device Correction letter, dated December 03, 2013, to consignees on December 10, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customer Actions: In the unlikely event that operation of your Propaq LT is interrupted and the display becomes blank or white, pressing the power (on/off) button will restart the device and quickly bring it back to full operational capacity. This notice should be passed on to all those who need to be aware within your organization, or to any organization where the potentially affected devices have been transferred. Welch Allyn is in the process of developing a software installation service tool that will enable installation of the software update by your biomed, IT staff or other technically qualified personnel. Upon release, the service tool will be made available to you via a download from Welch Allyn's website at www.welchallyn.com/PropaqltUpgrade or other media. In the meantime and on an on-going basis, the software update will be included if you schedule routine or other service with Welch Allyn or an authorized service provider. Customers with questions were instructed to call Welch Allyn Technical Support at 1-800-535-6663. For questions regarding this recall call 503-530-7935.

Device

Device Recall Propaq LT 802LT series Vital Signs Monitor
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to United Arab Emirates, Argentina, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Czech Republic, Germany, Denmark, Ecuador, Spain, France, United Kingdom, Greece, Hong Kong,Taiwan, Ireland, Italy, Japan, Korea, Republic of, Kuwait, Lithuania, Luxemborg, Mexico, Malaysia, Mozambique, Namibia, Netherlands, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Sierra Leone, El Salvador, Thailand, Turkey, Uganda, Vietnam, Kosovo, and South Africa.
  • 제품 설명
    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. || These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. || intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
  • Manufacturer
    Welch Allyn Protocol, Inc

Manufacturer

Welch Allyn Protocol, Inc
  • 제조사 주소
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • 제조사 모회사 (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA