Results: there was no visible damage to the exterior of the penumbra system aspiration pump max 220v (pump max).Conclusions: evaluation of the returned device revealed that the pump was functional.The pump was powered on multiple times and the pump generated vacuum each time it was powered on.Therefore, the root cause of the complaint cannot be determined.The pumps are 100% functional tested during incoming inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220v (pump max).During the procedure, the pump max did not produce any vacuum when the "on" power switch was pushed.Therefore, the physician completed the procedure using lyse-therapy.There was no report of an adverse effect to the patient.
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