Recall Z-1511-2017— Ohmeda Medical

Name: FDA recall Z-1511-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-18

Class II · Terminated

Class II FDA medical device recall by Ohmeda Medical, initiated 2016-11-18, terminated 2018-07-13. It names one FDA 510(k) clearance: K963058. Product: 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 modes: 1. Manual: The 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. Servo: The 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. Reason: 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..

Recalling firm: Ohmeda Medical
Classification: Class II
Status: Terminated
Initiated: 2016-11-18
Terminated: 2018-07-13
Firm location: Laurel, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K963058 — INFANT WARMER SYSTEMOhmeda Medical·cleared 1996-10-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 modes: 1. Manual: The 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. Servo: The 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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.