The Device’s Failure to Switch Power Sources Poses Risks of Ventilation Disruption, the FDA Warns.
The US Food and Drug Administration (FDA) has taken decisive action by issuing a Class I recall for Draeger Medical’s Oxylog 3000 Plus Emergency and Transport Ventilator, citing potential serious harm or even death.
Draeger Medical proactively initiated the recall on June 12 following six customer complaints about the ventilator ceasing to provide ventilation due to power rerouting malfunctions. Normally, when the battery is depleted, the system should seamlessly transition to AC power when connected. However, instances were reported where the system continued draining the battery without switching to AC power.
While no injuries or fatalities have been reported thus far, the FDA’s decision to classify the recall as Class I underscores the perilous nature of unexpected ventilation disruption. As stated in an FDA alert, patients could face respiratory distress, hypoxia, bradycardia, or cardiac arrest. Draeger Medical acknowledged that a battery alarm is activated during this issue.
German respiratory technology firm Draeger Medical has recalled 300 units of the Oxylog 3000 ventilator, which were distributed between April 2012 and June 2022. In a letter addressed to customers, the company outlined the necessary steps to ensure proper utilization of an AC main power supply for the device.
This recall compounds the challenges faced by Draeger Medical, following a previous recall of over 500,000 infant breathing circuit/anesthesia kits due to a manufacturing error.
In a separate development within the ventilator device sector, the FDA has also issued a recall for NOxBox’s NOxBOXi nitric oxide delivery system due to concerns of gas leakage.
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If you or a loved one have been affected by the recent FDA recall of Draeger’s Oxylog 3000 ventilator, it’s crucial to take action to safeguard your rights. At Parker Waichman LLP, we specialize in product liability cases and are ready to fight for the justice you deserve.
Don’t wait! Call our national injury hotline at 1-800-YOUR-LAWYER (1-800-968-7529) now to speak with our experienced team of product liability attorneys. We offer a free, no-obligation consultation to evaluate your case and provide guidance on the legal options available to you.
By contacting Parker Waichman LLP, and your case qualifies, can:
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Remember, time is of the essence. Strict deadlines apply to product liability claims, so don’t delay in seeking legal representation. Call Parker Waichman LLP at 1-800-YOUR-LAWYER (1-800-968-7529) now and take the first step towards protecting your rights and pursuing justice.
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Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products like this defective Oxylog 3000 Ventilator. For your free consultation, contact our national product liability law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).