Events

Unomedical high concentration oxygen masks (specific lots) 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 ConvaTec 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 연번
    MDA/2017/019
  • 날짜
    2017-07-10
  • 사례 출판 날짜
    2017-07-10
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/unomedical-high-concentration-oxygen-masks-specific-lots-risk-of-hypoxia-as-the-tubing-can-disconnect-from-the-oxygen-mask
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Manufactured by convatec – due to a manufacturing fault, the tubing may disconnect from the oxygen mask, prior to use or during use, causing a disruption in the supply of oxygen to patients (mda/2017/019).
  • 조치
    Identify and stop using affected devices (see below). Quarantine all affected devices in stock. Contact ConvaTec to acknowledge receipt of the Field Safety Notice (dated 10 May 2017) even if you don’t have affected devices left in stock For any product replacements required, see Field Safety Notice for further details

Device

Unomedical high concentration oxygen masks (specific lots)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    The following model (REF number) and LOT numbers are affected:Product Code / REF No. SAP Code Description LOT No’s. NHS Supply Chain Codes (NPC) FDD 104MM 1302097 Rebreathing mask, Reservoir bag, with Tubing 105631   106MM 1702436 Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7’) Oxygen Tubing 100733, 104106, 104798, 100721, 109824 763 108-E 1300168 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7’) Oxygen Tubing 102766, 102785, 102726, 102352, 105451, 109186   108MM 1705302 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7’) Oxygen Tubing 100281, 100709, 100729, 101923, 103180, 103265, 103691, 103714, 104104, 105987, 110558 2747 3226-E 1308753 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1 m (7’) Oxygen Tubing 102727   3226MM 1307553 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1 m (7’) Oxygen Tubing 100720, 101141   3230MM 1302405 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1 m (7’) Oxygen Tubing 104906, 105181 766 9108MM 1267152 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7’) Oxygen Tubing 100232, 100694, 100918, 101639, 101897, 103067, 104846, 104848, 105453
  • Manufacturer
    ConvaTec

Manufacturer

ConvaTec
  • 제조사 주소
    Rebecca Evans ConvaTec LimitedTelephone: 01244 284896
  • 제조사 모회사 (2017)
    Triona Holding Sa
  • Source
    MHRA