Alerte De Sécurité sur Stretcher, Mobile, Ambulance, Squadmate. (1) Model 93-ES, (2) Model 93-ESST, (3) Model 93-EX, (4) Model 93-EXST, Series Numbers (1 to 6) L-611423 to L-639535

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 Ferno Washington 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
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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
  • Cause
    Under excessive shock per load, the pin of the latch foot lock remains in the unlocked position and can bend, bend, bend. when bending, it can cause a locking in the pin that is collected instead of normally extended, which will cause the legs of the stretcher to remain unlocked at all times. using a stretcher without a catch on your feet is dangerous because it may fall suddenly. an unexpected drop can cause discomfort to the patient being transported or its operators. the manufacturer initiated a correction by an urgent correction news dated september 14, 2001.
  • Action
    Verify that you have received Urgent Correction News dated September 14, 2001 with replacement parts, containing the pins, installation instructions, order forms from other kits, and the prepaid envelope for the post to Ferno Washington. Identify and isolate any affected product from your inventory. Check the feet of each of the stretchers by testing the retractibility of the pins as follows: (1) Place the stretcher in the highest position. Remove the mat and / or lift the adjustment frame. Locate the span of the pins in the channel "C" on each side of the feet. (2) Note that the brass pins extend to lock the frame. When extended, the pins protrude out of the channel. Shaking to free the feet and change the position, causes the retraction of the pins and allows to move the structure. When the controls are released, the pins jump into the understood position, ready to engage when the frame rests back. (3) Make sure the pins are operating properly by releasing the controls several times and observing the movement of the pins. Both pins at the foot of the stretcher should extend and retract when the controls are shaken and released. If both pins retract after release of the control and the legs of the stretcher do not lock, this stretcher must be removed from service until the local Ferno Washington Service Representative can complete the replacement parts. Each set has number of series that correspond to the series numbers of the original products. If you choose to install the replacement part yourself, Ferno offers you, in return for your working time, a SAVER medical emergency kit, when you return the original part and the return set with the completed letter to the specified address. For more information or to have the installation service, contact your local Ferno Washington representative or directly at 1 (937)382-1451 in the USA.


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