No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Ge healthcare (gehc) reported a field modification for this issue per 21 cfr 806 on 05 december 2019.The fda recall number is z-0813-2020 & z-0814-2020.Customers were sent a letter explaining the issue and were provided the following safety instructions: you can continue to use the anesthesia system.If you observe the message ventilate manually, change from mechanical to manual ventilation.At any time, the clinician may use a self-inflating bag to ventilate the patient and/or switch to another anesthesia device.Contact your ge healthcare representative for repair of the device.Perform the planned maintenance (pm) every 12-months at a minimum per the user's reference manual which includes inspection of the cable connection.Note: this inspection step is included in the annual pm described in the technical reference manual.Performing this step in the pm would confirm the integrity of the cable connection.
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