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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 Problem Break
Event Date 09/01/2018
Event Type  Malfunction  
Manufacturer Narrative

The device has been returned and the investigation results are pending. A follow up mdr will be submitted upon completion of the device investigation.

 
Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220v (pump max). During the procedure, the pump max was found to be dysfunctional and the power button was broken.

 
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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 Key7930353
Report Number3005168196-2018-01968
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/01/2005,09/04/2018
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received10/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPMX220
Device LOT NumberF17185-29
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/27/2018
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 Manufactured08/10/2015
Is this a Reprocessed and Reused Single-Use Device? No

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