Events

Alerte De Sécurité sur ULTRASOM, PORTATIL

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 SON SITE 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
    93
  • Date
    2001-08-22
  • 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 IS NOT REGARDING PRODUCT REGISTRATION IN BRAZIL (SONOSITE INC. MANUFACTURER)
  • Cause
    The system contains an estimated date calculation error when using the nyberg obstetric calculator algarithm. the first of the 3 measures attributed gestacional saco (sg) is used to estimate of the expected date of department (dpp). sono site affirms that this situation does not present risk to the operator and the patient, since payments are not used to make decisions on patient health or fetal vitality in the first quarter of pregnancy.
  • Action
    THE MANUFACTURER BEGAN CORRECTION BY LETTER OF MAY 4, 2000 A FOLLOW UP LETTER WAS SHIPPED ON AUGUST 31, 2000. VERIFY THAT YOU HAVE RECEIVED THE SLEEP LETTER SITE CONTAINING THE UPDATE OF THE SOFTWARE MODULE P 01569-01, THE INSTRUCTIONS TO COMPLETE THE UPDATE (P 01691-01), THE LIST OF PARTS NUMBERS, THE NEW USER'S GUIDE DESCRIBING THE NEW FUNCTIONS OF THE UPDATED SYSTEM 9P 0719-05) AND THE PRE-PAYED PACKAGE TO RETURN THE OBSOLETE MODULE. TO CONFIRM THAT YOUR MODULE 180 OF THE SYSTEM IS AFFECTED: 1 - SEE THE LABEL BELOW THE SYSTEM AND ENTER THE PART NUMBER (PO XXXX); 2 - ACCESS THE MONITOR, THE INFORMATION SYSTEM, PLACE THE SYSTEM "ON", TIGHTEN THE "FUNCTION" KEY, AND KEY "I" AND CHECK THE SOFTWARE VERSION INDICATED ON THE "ARM VIEW" LINE OF THE MONITOR. 3- IF THE PART NUMBER AND THE COMBINED ARM VERSION WERE EQUAL TO WHICH ARE PRESENTED ON THE LIST ABOVE, DO NOT USE THE NYBERG GS OBSTETRIC ALGARITHM TO CALCULATE DPP. AS SOON AS POSSIBLE, COMPLETE THE SYSTEM UPDATE, PLACE THE OBSOLETE MOCLEAR IN THE PRE-PAYMENT PACKAGE OR PICK THE PRE-PAYED LABEL INTO THE ORIGINAL BOX, WATERPROOF, PLACING ON A PLASTIC AND NOTIFY THE UPS TO PICK THE PACKAGE. SONO SITE RECOMMENDS THAT THE CALCULATION ALGARITHM OF THE DPP IS NOT USED UNLESS IT IS UPDATED. FOR FURTHER INFORMATION, CONTACT THE SLEEP TECHNICAL SUPPORT ON THE PHONE (877)657-8118 OR (425) 951-1030 E-MAIL SERVICE@SONOSITE.COM

Device

ULTRASOM, PORTATIL

Manufacturer

SON SITE INC
  • Source
    ANVSANVISA