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U.S. Department of Health and Human Services

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

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PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 JCX Back to Search Results
Catalog Number PMX110
Device Problems Bent; Break; Device Contamination with Chemical or Other Material
Event Date 07/24/2017
Event Type  Malfunction  
Manufacturer Narrative

Results: the power inlet on the back of the penumbra system aspiration pump max 110 (pump max) was damaged. Conclusions: evaluation of the returned device revealed that the pump max power inlet was loose. The pump max was plugged in and powered on and functioned without an issue. However, the power inlet on the back of the pump max was damaged and, therefore, the pump max was deemed nonfunctional. The reported issues of the power inlet being full of plastic, bent, and the power cord not being able to be plugged in could not be confirmed. Penumbra pump maxs are 100% functionally tested during incoming inspection by quality. 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 110 (pump max). During the procedure, the technician found that the bracket for the power inlet on the pump max was broken, full of plastic, and was bent; therefore the power cord was unable to be plugged in. The power inlet was cleaned out, and the procedure was continued using the pump max. There was no report of an adverse effect to the patient.

 
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Brand NamePENUMBRA SYSTEM ASPIRATION PUMP MAX 110
Type of DeviceJCX
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda , CA 94502
5107483200
MDR Report Key6812027
Report Number3005168196-2017-01401
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,07/25/2017
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received08/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX110
Device LOT NumberF21355-26
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/09/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received01/14/2005
Date Device Manufactured03/21/2016
Is this a Reprocessed and Reused Single-Use Device? No

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