MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220; NRY

Model Number	PMX220
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220 (pump max).During the procedure, the hospital staff noticed that for the pump max to stay powered on, the on/off button had to be always pressed down.The procedure was completed using the same pump max.There was no report of an adverse effect to this patient.
Additional Manufacturer Narrative
Evaluation of the returned pump max revealed a functional device.During the functional test, the pump max was power on and the power button functioned without an issue.The power button was cycled on/off multiple times without an issue.The pump max was able achieve vacuum pressure within specification.The reported complaint could not be confirmed.Penumbra pumps are visually inspected and functionally tested during incoming inspection by quality.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 220
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11220001
• Report Number: 3005168196-2021-00158
• Device Sequence Number: 3861640
• Product Code: NRY
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Model Number: PMX220
• Device Catalogue Number: PMX220
• Device Lot Number: F21927-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/31/2020
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 01/23/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005