MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA ENGINE; DXE

Model Number PMXENGN-A

Device Problems Failure to Power Up (1476); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

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 using a penumbra engine (engine).During the procedure, the engine fell off the cart and was unable to power back on.Therefore, the engine was disconnected.It is unknown how the procedure was completed.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the engine was plugged in and the power button was pressed, but the device did not power on.The fuses on the back of the engine were replaced with known good fuses, and the engine was able to power on.The engine was tested with a demonstration canister and produced vacuum pressure within specification and all four vacuum indicator lights illuminated.Conclusions: evaluation of the returned engine confirmed that the device was unable to power on and revealed blown fuses.This damage was likely the result of the reported engine falling on the floor.During functional testing, the engine was plugged in and the power button was pressed but the device did not power on.The fuses on the back of the engine were replaced with known good fuses and the engine was able to power on.The engine was able to produce vacuum pressure within specification and all four vacuum indication lights illuminated.Penumbra engines are inspected at incoming quality control which includes a visual inspection as well as a verification of test results to ensure specifications for each output are met.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA ENGINE
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10375859
• MDR Text Key: 201935366
• Report Number: 3005168196-2020-01115
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00815948020023
• UDI-Public: 00815948020023
• Combination Product (y/n): Y
• PMA/PMN Number: K180105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PMXENGN-A
• Device Catalogue Number: PMXENGN
• Device Lot Number: S10152-18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1