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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 Smoking; Suction Problem
Event Date 09/22/2019
Event Type  Malfunction  
Manufacturer Narrative

This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.

 
Event Description

The patient was undergoing a thrombectomy procedure in the common carotid artery (cca)/right internal carotid artery (ica) using a penumbra system aspiration pump max 220 (pump max). During the procedure, the pump max started emitting smoke and stopped working. The physician was unable to turn the pump max back on and there was no aspiration. Therefore, the pump max was disconnected and the procedure was completed using a manual aspiration with a syringe. There was no report of an adverse effect to the patient.

 
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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 Key9221921
Report Number3005168196-2019-01971
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,09/23/2019
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received10/22/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPMX220
Device LOT NumberF17185-03
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/24/2019
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 Received11/08/2019
Date Device Manufactured08/10/2015
Is this a Reprocessed and Reused Single-Use Device? No

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