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U.S. Department of Health and Human Services

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

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PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 JCX Back to Search Results
Catalog Number PMX220
Device Problems No Audible Prompt / Feedback ; Device Damaged Prior to Use ; Pumping Problem
Event Date 08/23/2018
Event Type  Malfunction  
Manufacturer Narrative

The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

 
Event Description

During preparation for a thrombectomy procedure, the hospital staff found that a penumbra system aspiration pump max 220 (pump max) was not working, despite the green button being pressed. It was reported that the pump max was not producing any sound or vibration. The damage to the pump max was found prior to use and, therefore, it was not used in the procedure. The procedure was completed using a stent retriever.

 
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Brand NamePENUMBRA SYSTEM ASPIRATION PUMP MAX 220
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 Key7894634
Report Number3005168196-2018-01868
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,08/24/2018
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received09/20/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPMX220
Device LOT NumberF16655-01
Was Device Available For Evaluation? No
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 Received08/24/2018
Date Device Manufactured06/11/2015
Is this a Reprocessed and Reused Single-Use Device? No

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