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Catalog Number PMX110 |
Device Problems
Device Emits Odor (1425); Smoking (1585); Device Operational Issue (2914); Noise, Audible (3273)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/30/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Results: there was no visible damage to the exterior of the penumbra system aspiration pump max 110v (pump max).Conclusions: evaluation of the retuned 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.Furthermore, no unusual scents or sounds were detected coming from the pump.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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Event Description
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The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110v (pump max).During the procedure, the pump max started smoking, making noises and smelling.The procedure was completed using the same pump max; however, the physician had to turn the pump max off and on multiple times throughout the procedure.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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