Events

Recall of Device Recall DeVilbiss Model DV5x Series CPAP with Heated Humidifier

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sunrise Medical HHG Inc. dba DeVilbiss Healthcare.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59042
  • Event Risk Class
    Class 2
  • Event Number
    Z-2990-2011
  • Event Initiated Date
    2011-03-11
  • Event Date Posted
    2011-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100885
  • Notes / Alerts
    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.
  • Extra notes in the data
    Ventilator, non-continuous (respirator) - Product Code BZD
  • Reason
    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
  • Model / Serial
    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.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
  • Manufacturer Address
    Sunrise Medical HHG Inc. dba DeVilbiss Healthcare, 100 DeVilbiss Drive, Somerset PA 15501-2125
  • Source
    USFDA