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U.S. Department of Health and Human Services

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

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PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V JCX Back to Search Results
Catalog Number PMX220
Device Problems Break; Device Damaged Prior to Use ; No Pressure
Event Date 12/23/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.

 
Event Description

During preparation for a procedure, the physician noticed the penumbra system aspiration pump max 220 (pump max) pressure regulator was broken, and that it was unable to produce any vacuum. The damage to the pump max was noticed prior to use; therefore, it was not used in the procedure. The procedure was continued using manual aspiration.

 
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Brand NamePENUMBRA SYSTEM ASPIRATION PUMP MAX 220V
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 Key6263644
Report Number3005168196-2017-00094
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/23/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/19/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPMX220
Device LOT NumberF22416-17
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/09/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/06/2016
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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