Anesthesia Workstation Recall Issued Due to Risk of Serious Injury, Death
Federal health officials have issued a class 1 recall for Spacelabs Anesthesia Workstations, indicating that the device may pose a threat of serious and potentially life-threatening complications.
On Tuesday, the FDA designated a Spacelabs Anesthesia Workstations and Service Kits recall a Class I medical device recall.
The recall was originally issued by Spacelabs Healthcare Inc. on January 15, due to faulty absorbers in the workstations and service kits that can malfunction, causing serious problems during surgery. The workstations are typically used in hospital settings by anesthesiologists.
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A class 1 recall is the most serious classification of recall. They are only issued when there is potential that the product may cause serious injury and may potentially result in death. However, there have been no reported cases of serious injury or death associated with the recalled anesthesia workstations.
The anesthesia workstations function by providing patients with a continuous supply of oxygen and nitrous oxide during surgical procedures in a controlled and precise manner. The workstations are often used with a mechanical ventilator to deliver anesthetic vapor as well. The defect in the absorbers may cause an increase of carbon dioxide concentration within the gases during surgery.
Carbon dioxide is a gaseous byproduct of the body’s metabolism and is expelled through the lungs. Excess carbon dioxide in the body’s system can cause serious consequences, like reduced neural activity, increased blood pressure, lethargy, disorientation, convulsions, unconsciousness and eventually death.
The recall affects the Blease Sirius and Blease Focus Anesthesia Workstations which are manufactured by Del Mar Reynolds Medical in Hertford, United Kingdom, and shipped from October 31, 2012, through January 15, 2013. The service kits which are affected contain part numbers 12200902, 050-0659-00, 050-0901-00 and any workstation containing a CAS I/II Absorber from a Service Kit.
The FDA advises patients and healthcare providers to stop using the workstations and service kits immediately.
The Issaquah, Washington based Spacelabs issued an urgent-medical device correction to the affected customers warning them of the recall. Any side effects or problems concerning the workstations can be reported to the FDA’s MedWatch Safety Information and Adverse Event reporting program. Customers can also contact Spacelab’s technical support team with questions regarding the recall at 800-522-7025.
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