Device Recall Babytherm 8004/8010

  • Model / Serial
    Serial Numbers: ARLN-xxxx to ASFE-xxxx Catalog Numbers: FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004)
  • Product Classification
  • 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
  • 1 Event

Manufacturer

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