Events

Rappel de Device Recall DeVilbiss Model DV5x Series CPAP with Heated Humidifier

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 Sunrise Medical HHG Inc. dba DeVilbiss Healthcare.

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
    59042
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2990-2011
  • Date de mise en oeuvre de l'événement
    2011-03-11
  • Date de publication de l'événement
    2011-08-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-10-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100885
  • 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
    Ventilator, non-continuous (respirator) - Product Code BZD
  • Cause
    Some units were manufactured with a defective humidifier chamber o-ring. unit could leak, allowing water to escape during use, causing damage to furniture.
  • Action
    The firm, DeVilbiss Healthcare, issued a "URGENT: MEDICAL DEVICE CORRECTION" letter dated March 11, 2011 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to verify their inventory of CPAPs with Heated Humidifiers and isolate any units that are included in the list; replace the humidifier chamber o-rings with the new ones provided; discard the original o-ring removed from the humidifier chamber; complete and return the URGENT: MEDICAL DEVICE CORRECTION Confirmation letter via mail to Quality Manager, DeVilbiss Healthcare LLC, 100 DeVilbiss Drive, Somerset, PA, 15501; affirm that all units have been corrected and that all end users have been sent replacement parts, when all of the CPAPs on the serial number list have been corrected, and return a copy of the sign serial number sheet as confirmation. If you have any questions regarding the information provided in this communication, please contact DeVilbiss Healthcare Customer Service at 1-800-388-1988 from 8:00AM-5:00PM EST.

Device

Device Recall DeVilbiss Model DV5x Series CPAP with Heated Humidifier
  • Modèle / numéro de série
    Model number DV5HH, serial number range from HH073341 to HH077139.  Model number DV51D-HH, serial number range from ID022837 to ID023117.  Model number DV53-HH, serial number range from JD004065 to JD004224.  Model number DV54D-HH, serial number range from HD023473 to HD024014.  Model number DV55D-HH, serial number range from KD005598 to KD005695.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution; USA (nationwide) including states of AL, AR, CA, FL, IL, IN, IA, KS, KY, MD, MA, MI, MS, NE, NJ, NY, OH, PA, WA, WV, and WI; and countries of Europe.
  • Description du dispositif
    DeVilbiss Model DV5x Series CPAP with Heated Humidifier || Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient's airway to prevent collapse of the airway while the patient is sleeping. The heated humidifier provides additional humidity to the air supplied to the patient. The heated humidifier has a removable water chamber for filling with water and ease of cleaning.
  • Manufacturer
    Sunrise Medical HHG Inc. dba DeVilbiss Healthcare

Manufacturer

Sunrise Medical HHG Inc. dba DeVilbiss Healthcare
  • Adresse du fabricant
    Sunrise Medical HHG Inc. dba DeVilbiss Healthcare, 100 DeVilbiss Drive, Somerset PA 15501-2125
  • Source
    USFDA