Recall Z-1510-2017
Ohmeda Medical · initiated November 18, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: See Attached Spreadsheat
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1510-2017
- Initiated
- November 18, 2016
- Terminated
- July 13, 2018
- Product code
- FMZ – Incubator, Neonatal
- Quantity
- 5,993 (5,080 US; 913 OUS)
- 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,
- Recalling firm
- Ohmeda Medical, Laurel, MD
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1501-2017 Class II | Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | 11/18/2016Terminated |
| Z-1502-2017 Class II | Giraffe Incubator The Giraffe Incubator is an infant incubator. Incubators provide heat…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | 11/18/2016Terminated |
| Z-1503-2017 Class II | Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | 11/18/2016Terminated |
| Z-1504-2017 Class II | Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | 11/18/2016Terminated |
| Z-1505-2017 Class II | Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | 11/18/2016Terminated |
| Z-1506-2017 Class II | Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | 11/18/2016Terminated |
| Z-1507-2017 Class II | Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | 11/18/2016Terminated |
| Z-1508-2017 Class II | Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | 11/18/2016Terminated |
| Z-1509-2017 Class II | Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | 11/18/2016Terminated |
| Z-1511-2017 Class II | IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | 11/18/2016Terminated |