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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V JCX

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PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V JCX Back to Search Results
Catalog Number PMX220
Device Problems Device Operational Issue; No Pressure
Event Date 02/22/2016
Event Type  Malfunction  
Manufacturer Narrative

Results: the pump was powered on for 30 minutes and functioned without an issue. There was no visible damage to the pump. Conclusions: evaluation of the returned device revealed that the pump was functional. The pump was powered on for 30 minutes and functioned without an issue. The root cause of this complaint could not be determined. Pumps are 100% functionally tested during incoming inspection. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

 
Event Description

The patient was undergoing a thrombectomy procedure in the basilar artery using a penumbra system aspiration pump max 220v (pump max). During the procedure, after aspirating thrombus for approximately 20 minutes, the pump max unexpectedly stopped producing vacuum and the gauge read zero. The procedure was completed using a stent retriever. There was no report of an adverse effect to the patient.

 
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Brand NamePENUMBRA SYSTEM ASPIRATION PUMP MAX 220V
Type of DeviceJCX
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer (Section G)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
kathleen kidd
one penumbra place
alameda , CA 94502
5107483200
MDR Report Key5514970
Report Number3005168196-2016-00351
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 02/23/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/21/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX220
Device LOT NumberF17185-33
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/14/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/10/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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