FLUSHING PUMP OFP-2 (JP)
Report
- Report Number
- 9611174-2024-01554
- Event Type
- Malfunction
- Date Received
- September 25, 2024
- Date of Event
- September 6, 2024
- Report Date
- January 7, 2025
- Manufacturer
- KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
- Product Code
- FEQ
- PMA / PMN Number
- K100899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE MOST PROBABLE CAUSE OF REPORTED EVENT IS COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
IT WAS REPORTED THE SUBJECT DEVICE LIGHT-EMITTING DIODE OF POWER SUPPLY DID NOT LIGHT UP. THERE WERE NO REPORTS OF PATIENT HARM.
ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: MALFUNCTION WAS IDENTIFIED BEFORE PROCEDURE DURING PRE-TEST INSPECTION FOR A DIAGNOSTIC TYPE OF PROCEDURE. THE PROCEDURE WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1243161 | FLUSHING PUMP OFP-2 (JP) | OLYMPUS FLUSHING PUMP | FEQ | KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. | K10001142 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | CV-1500-EVIS X1 VIDEO SYSTEM CENTER.| K10035362-WM-NP3 MOBILE WORKSTATION JP.| UCR-ENDOSCOPIC CO2 REGULATION UNIT. |