MONARCH PLATFORM
Report
- Report Number
- 3014447948-2022-00034
- Event Type
- Malfunction
- Date Received
- September 27, 2022
- Date of Event
- September 6, 2022
- Report Date
- September 27, 2022
- Manufacturer
- AURIS HEALTH, INC.
- Product Code
- EOQ
- UDI-DI
- B634MON000005010
- PMA / PMN Number
- K211493
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE FIELD SERVICE ENGINEER (FSE) WENT ONSITE PERFORMED A PHYSICAL INSPECTION OF THE CAMERA PATHWAY, PERFORMED A FUNCTIONAL CHECK OF THE VISION PATHWAY USING A SCOPE AND WAS NOT ABLE TO REPLICATE THE ISSUE. AS SUCH, A CAUSE COULD NOT BE DETERMINED. NO REVIEW OF THE DEVICE HISTORY RECORD (DHR) IS NECESSARY AS THE ISSUE COULD NOT BE CONFIRMED OR REPLICATED. A REVIEW FOR SIMILAR REPORTED ISSUE NOTES THIS TO BE A KNOWN ISSUE BUT HAS NOT ESTABLISHED A POSSIBLE ROOT CAUSE. THE RISK ASSOCIATED WITH THE REPORTED ISSUE IS NOTED IN: RISK DOCUMENT NUMBER: 105-000367-00, REV. M, DFMEA BRONCH 2.0 RISK ID: FMEA-1240 & FMEA-0510.
IT WAS REPORTED THE PHYSICIAN LOST THE LIVE CAMERA IMAGE AFTER COMPLETING THE NAVIGATION REGISTRATION AND STARTED TO DRIVE OUT TO THE TARGET. THE PHYSICIAN PROACTIVELY POWER CYCLED THE SYSTEM AND CHANGED OUT THE SCOPE; HOWEVER THE ISSUE PERSISTED. THE PHYSICIAN WAS UNABLE TO PERFORM THE MONARCH PROCEDURE DUE TO THE SYSTEM RELATED ISSUE, THE CASE WAS ABORTED AND RESCHEDULED FOR A LATER DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1952771 | MONARCH PLATFORM | BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES | EOQ | AURIS HEALTH, INC. | MON-000005-01 | B634MON000005010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |