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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 Device Operates Differently Than Expected; No Pressure
Event Date 03/02/2016
Event Type  Malfunction  
Manufacturer Narrative

Results: there was no visible damage to the penumbra system aspiration pump max 110v (pump max). Conclusions: evaluation of the returned device revealed that the pump was functional. The pump was powered on and off multiple times and functioned without an issue each time. Therefore, the pump was functional. 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 using a penumbra system aspiration pump max 110v (pump max). During the procedure, after the hospital technologist powered on the pump max, the fan produced a noise; however, the pump max did not produce a vacuum. After depressing the green power button several times and making repeated attempts, the pump max eventually started producing vacuum. The procedure was successfully 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 Key5540086
Report Number3005168196-2016-00404
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/02/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/31/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX110
Device LOT NumberF12456-30
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/09/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/21/2014
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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