Events

Recall of Device Recall Babytherm 8004/8010

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

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
    74523
  • Event Risk Class
    Class 2
  • Event Number
    Z-2295-2016
  • Event Initiated Date
    2016-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147829
  • 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
    Warmer, infant radiant - Product Code FMT
  • Reason
    Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
  • Action
    Drager mailed to customers an Urgent Medical Device Recall Notification Letter dated June 22, 2016 to affected customers. The letter identified the affected product, problem information on how to operate the device and replacement of parts information. For questions regarding this letter please call 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Dr¿ger Babytherm 8004/8010 please contact Dr¿gerService Technical Support at 1-800-543-5047 (press 4 at the prompt).

Device

Device Recall Babytherm 8004/8010
  • Model / Serial
    Serial Numbers: ARLN-xxxx to ASFE-xxxx Catalog Numbers: FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including Puerto Rico and the states of AK,AL,AR,CA,CO,CT,DE,FL,GA,HI,IA,IL,IN,KS,KY,LA,MA,MD,MI,MN,MO,MS,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TS,TX,UT,VA,WA,WI,WV, and WY.
  • Product Description
    Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. || Product Usage: || Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates and infants with a body weight of up to 8 kg (17.6 lbs). The device is intended for use in delivery rooms, operating rooms, maternity and obstetric units, neonatal and pediatric wards, neonatal and pediatric intensive care units. Therapy and nursing uses: - As a resuscitation table and in birthing rooms, obstetric units, and NICUs - As infant warmer bassinet during normal and intensive care - For infant re-warming and compensation of heat loss - For thermal stabilizing of infants with mattress heater (Babytherm 8010 only) - For gentle warming therapy using the combination of radiant and mattress heater - Cooling infants with fever (temperature of mattress below infant body temperature, Babytherm 8010 only) - With adjustable bed tilt for treatment of infants in Trendelenburg and reverse Trendelenburg position - For weaning infants from incubators - For O2 and nebulizer therapy (with appropriate accessories) - For lowering an infant s bilirubin levels when using the phototherapy option
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • Manufacturer Address
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Source
    USFDA