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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V JCX

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PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V JCX Back to Search Results
Catalog Number PMX110
Device Problems Pumping Stopped; No Pressure
Event Date 04/11/2016
Event Type  Malfunction  
Manufacturer Narrative

Results: the penumbra system aspiration pump max 110v (pump max) was opened by the penumbra investigator and no damage or abnormalities were observed. Conclusions: evaluation of the returned device revealed that the pump was functional. The pump was plugged in and powered on and aspiration was present. The vacuum was fully adjustable and, therefore, functional. The pump was opened by the penumbra investigator and no damage or abnormalities were observed. The root cause of this complaint could not be determined. Pumps are 100% functionally tested during in-process 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 using a penumbra system aspiration pump max 110v (pump max). During the procedure, while the pump max was being used to aspirate clot, it was noticed that the pump max was not making any noise and had also stopped aspirating. The pump max started working normally again after it was powered off and back on. The procedure was completed using the same pump max. There was no report of an adverse effect to the patient.

 
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Brand NamePENUMBRA SYSTEM ASPIRATION PUMP MAX 110V
Type of DeviceJCX
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
kathleen kidd
one penumbra place
alameda , CA 94502
5107483200
MDR Report Key5648465
Report Number3005168196-2016-00643
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/11/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/11/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX110
Device LOT NumberF07119-05
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/25/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/13/2014
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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