CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal envir...
FDA Device Recall #Z-1510-2017 — Class II — November 18, 2016
Recall Summary
| Recall Number | Z-1510-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 18, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ohmeda Medical |
| Location | Laurel, MD |
| Product Type | Devices |
| Quantity | 5,993 (5,080 US; 913 OUS) |
Product Description
CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. Most Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. Most incubators can be used in two operating modes: 1. Air Control: The clinician sets the appropriate air temperature for maintaining the desired patient temperature. The air temperature is initially selected based on the clinician s training and experience and then is adjusted based on the patient s needs and clinical status. 2. Patient control: The clinician sets the desired patient temperature. A skin temperature probe sense the patient temperature and feeds this information to the controller of the incubator. Thecontroller 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. Incubators 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. Incubators may incorporate other features, such as humidification of the infant environment, tilting of the bed, oxygen supply, 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.
Distribution Pattern
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,
Lot / Code Information
See Attached Spreadsheat
Other Recalls from Ohmeda Medical
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0041-2020 | Class II | Giraffe Omnibed - Product Usage: The OmniBed is... | Oct 5, 2018 |
| Z-1181-2018 | Class II | Rotating IV Pole Rotating IV Pole falls un... | Dec 1, 2017 |
| Z-1509-2017 | Class II | Giraffe OmniBed Ohmeda Medical Omnibed- The Om... | Nov 18, 2016 |
| Z-1502-2017 | Class II | Giraffe Incubator The Giraffe Incubator is an ... | Nov 18, 2016 |
| Z-1511-2017 | Class II | IWS Infant Warmer System-Infant radiant warmer... | Nov 18, 2016 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.