VC10 PUMP, 115V
Report
- Report Number
- 3011050570-2025-00001
- Event Type
- Malfunction
- Date Received
- January 2, 2025
- Date of Event
- November 18, 2024
- Report Date
- March 10, 2025
- Manufacturer
- GYRUS ACMI, INC.
- Product Code
- HHK
- PMA / PMN Number
- K171440
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NO CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
REQUEST FOR CORRECTION ON D2 PROCODE WHICH WAS SUBMITTED IN ERROR AS FDF BUT WAS INTENDED TO BE HHK. UPDATE TO G4 510K NUMBER WHICH WAS PREVIOUSLY K030935 AND WAS UPDATED TO K171440.
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
IT WAS REPORTED THAT WHILE USING THE VC10 PUMP, 115V IT JUST REMAINED AT MAXIMUM SUCTION. THE REPORTED MALFUNCTION OCCURRED DURING SET UP AND INSPECTION FOR USE PRIOR TO AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421530 | VC10 PUMP, 115V | VC10 PUMP, 115V | HHK | GYRUS ACMI, INC. | VC-10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |