• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX JCX Back to Search Results
Catalog Number PMX220
Device Problems Device Emits Odor; Device Damaged Prior to Use ; No Pressure
Event Date 03/02/2016
Event Type  Malfunction  
Manufacturer Narrative

Result: the pump was powered on and functioned without an issue. There was no visible damage to the pump. Conclusion: evaluation of the returned device revealed that the pump was functional. The root cause of the pump not producing vacuum could not be determined. The pump was functionally tested and functioned without an issue. Pumps are 100% functionally tested during in-process 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 220v (pump max). During preparation for the procedure, the hospital staff noticed that when the pump max was switched on, it did not produce vacuum and also emitted a smell. The defective pump max was found prior to use and was not used for the procedure; instead, a syringe was used for the procedure. There was no report of an adverse effect to the patient.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePENUMBRA SYSTEM ASPIRATION PUMP MAX
Type of DeviceJCX
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer (Section G)
PENUMBRA, INC.
Manufacturer Contact
kathleen kidd
one penumbra place
alameda , CA 94502
5107483262
MDR Report Key5542606
Report Number3005168196-2016-00389
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
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 Received04/01/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX220
Device LOT NumberF15888-24
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/29/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-