Reported Mar 29, 2017 · Terminated
IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are…
Ohmeda Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ohmeda Medical · 8880 Gorman Rd · Laurel, MD · 20723-5800
Is this the product you have?
- IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat to smoothen the transition from the uterus to the external environment. They fulfill the same purpose of neonatal incubators but they may be preferred over incubators when total access to the patient is needed or desirable (e.g., surgical procedures, extracorporeal membrane oxygenation, frequent resuscitation, etc.). Most infant radiant warmers
- can be used in two operating modes1
- ManualThe clinician sets the appropriate heater output for maintaining the desired patient temperature. The heater output is initially selected based on the clinician s training and experience and then is adjusted based on the patients needs and clinical status. 2
- ServoThe clinician sets the desired patient temperature. A skin temperature probe senses the patient temperature and feeds this information to the controller of the infant radiant warmer. The controller then adjusts the heater output to maintain the patient temperature at the set value. These adjustments to the heater output are made in such a way to gradually change the patient s temperature while minimizing overshooting and patient stress. Infant radiant warmers have alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient s temperature from the set value. Infant radiant warmers may incorporate other features, such as phototherapy, observation light, tilting of the bed, and data output to remote monitors or nurse call systems
- Lot codes and dates
- See Attached Spreadsheat
- Amount recalled
- 5,993 (5,080 US; 913 OUS)
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.
This product could cause temporary or reversible health problems — stop using it.
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