Device Recall Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ohmeda Medical 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
    76283
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1507-2017
  • 사례 시작날짜
    2016-11-18
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2018-07-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Warmer, infant radiant - Product Code FMT
  • 원인
    Certain power cords could overheat. the affected power cords were manufactured by electric-cord and are referred to as taller bridge power cords. the overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.
  • 조치
    According to the firm, this issue will be resolved by sending an Urgent Medical Device Correction customer letter to customers with affected Power Cords. This letter will inform the customer of the issue and provide safety instructions for immediate mitigation of the issue. The long-term solution is to re-place all affected Power Cords at no cost to the customer. According to the firm, the plan for public notification is to contact all customers with affected Power Cords by means of an Urgent Medical Device Correction letter. In the US this will be sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX). This letter will be sent to the following titles within the affected accounts; Nurse Managers, Labor & Delivery/NICU, Bio-Medical Engineering Department Managers and Risk Management Directors We will track all service requests for the field action to completion. These service requests will record the replacement of the affected Power Cords. Exceptions to completion of the service request will be recorded as well. Records of field action completion will be retained per our processes and procedures.

Device

  • 모델명 / 제조번호(시리얼번호)
    See Attached Spreadsheat
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide and Puerto Rico) Bahamas and Internationally to UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela,
  • 제품 설명
    Giraffe Bedded Warmer, Panda Warmer || Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) - Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP02 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Ohmeda Medical, 8880 Gorman Rd, Laurel MD 20723-5800
  • 제조사 모회사 (2017)
  • Source
    USFDA