Events

Recall of Device Recall Infant Warmer System

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

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
    76283
  • Event Risk Class
    Class 2
  • Event Number
    Z-1511-2017
  • Event Initiated Date
    2016-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152644
  • 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
    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.
  • Action
    According to the firm, this issue will be resolved by sending an Urgent Medical Device Correction customer letter to customers with affected Power Cords. This letter will inform the customer of the issue and provide safety instructions for immediate mitigation of the issue. The long-term solution is to re-place all affected Power Cords at no cost to the customer. According to the firm, the plan for public notification is to contact all customers with affected Power Cords by means of an Urgent Medical Device Correction letter. In the US this will be sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX). This letter will be sent to the following titles within the affected accounts; Nurse Managers, Labor & Delivery/NICU, Bio-Medical Engineering Department Managers and Risk Management Directors We will track all service requests for the field action to completion. These service requests will record the replacement of the affected Power Cords. Exceptions to completion of the service request will be recorded as well. Records of field action completion will be retained per our processes and procedures.

Device

Device Recall Infant Warmer System
  • Model / Serial
    See Attached Spreadsheat
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide and Puerto Rico) Bahamas and Internationally to UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela,
  • 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
  • Manufacturer
    Ohmeda Medical

Manufacturer

Ohmeda Medical
  • Manufacturer Address
    Ohmeda Medical, 8880 Gorman Rd, Laurel MD 20723-5800
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA