Events

Alerte De Sécurité sur ELECTRODE ADAPTERS, CABELUDO LEATHER, FETAL, SAFECONNECT DECG MODEL M1347A; ADAPTERS USED TO CONNECT THE ADAPTER CABLE TO THE SAFECONNECT DECG LEG PLATE, MODEL M1362B, TO THE DECG MODEL TRANSDUCER MODEL M1357A (FOR AGILENT / HP PHOTOS 50 SERIES 50: MODELS M1350A, B, C; M1351A; E M1353A) AND MODG TRANSDUCER MODEL 15240A (FOR AGILENT / HP FACTORY MONITORS MODEL 8040A). ADAPTERS WITHOUT DATE OR CODE.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par AGILENT TECHNOLOGIES INC..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    75
  • Date
    2001-05-11
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    The electrical connection is low between adapters and other accessories to measure the electrocardiography, which may cause losses or interference of the electrocardiographic sign, ecg, which may result in the inability to monitor the rate of fitness heart beatings. the distributor began removal and replacement by letter sent in december.
  • Action
    VERIFY THAT YOU HAVE RECEIVED THE DECEMBER 2000 LETTER, WITH THE NEWS OF URGENT REMOVAL AND REPLACEMENT WITH THE NEW ADAPTERS FOR MODEL M1347A, WITH CODE AND DATE, LABELS FOR RETURN AND ENVELOPES OF AGILENT. IDENTIFY AND ISOLE ANY OF THESE PRODUCTS THAT ARE IN YOUR INVENTORY. REPLACE ADAPTERS AFFECTED WITH NEW SENDERS. RETURN AFFECTED REPLACEMENTS USING ENVELOPES AND LABELS AS INDICATED. FOR FURTHER INFORMATION OR IF YOU WISH TO COMMUNICATE THAT YOU DO NOT HAVE ANY OF THE PRODUCTS AFFECTED, CONTACT AGILENT NO 0021-1-880-668-4391

Device

ELECTRODE ADAPTERS, CABELUDO LEATHER, FETAL, SAFECONNECT DECG MODEL M1347A; ADAPTERS USED TO CONN...

Manufacturer

AGILENT TECHNOLOGIES INC.
  • Source
    ANVSANVISA