Events

Rappel de Device Recall eValueMed Infant Transport Mattress

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Electronics North America Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    73281
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1317-2016
  • Date de mise en oeuvre de l'événement
    2016-02-10
  • Date de publication de l'événement
    2016-04-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143732
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Pack, hot or cold, disposable - Product Code IMD
  • Cause
    Evaluemed infant heel warmers and evaluemed infant transport mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.
  • Action
    Philips sent an Urgent Medical Device Recall leter dated January 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: Actions for Tri-Anim Customers to Take 1.) Discontinue use of eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses. 2.) Check for any inventory of eValueMed Infant Heel Warmers or eValueMed Infant Transport Mattresses. 3.) Destroy all products on hand (e.g., by activating or puncturing each unit). Make a note of the total number of cases of products that were destroyed as this will be needed for step 4 below. 4.) Complete and sign the Customer Reply Form provided in this letter or Tri-anims version thereof, to notify Tri-anim of how many eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses were destroyed. Submit your signed reply form only after you have completed all steps. Please do not return any product to Philips. Customers with questions should call 336-449-5230 or 262-798-9802. For questions regarding this recall call 978-659-3000.

Device

Device Recall eValueMed Infant Transport Mattress
  • Modèle / numéro de série
    All in distribution.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution to Ohio only.
  • Description du dispositif
    eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima || A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Adresse du fabricant
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA