FDA Adverse Event Malfunction Summary report: N

ROSA ONE BRAIN

MDR report key: 17445794 · Received August 2, 2023

Report

Report Number: 3009185973-2023-00019
Event Type: Malfunction
Date Received: August 2, 2023
Date of Event: May 4, 2023
Report Date: August 2, 2023
Manufacturer: MEDTECH SAS
Product Code: HAW
UDI-DI: 03760244032492
PMA / PMN Number: K200511
Removal / Correction Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

(B)(4). THE SUBJECT DEVICE WAS EVALUATED BY A FSE ON-SITE. IT WAS REPORTED THAT THE FSE UPGRADED THE SOFTWARE AND REPLACED THE CPU BOARD OF THE CONTROLLER. THE SYSTEM WAS OPERATIONAL, AND ALL FUNCTIONAL CHECKS PASSED AFTER THIS VISIT. AS THE ISSUE WAS DETERMINED TO BE RELATED TO HARDWARE, A REVIEW OF THE LOG FILES WAS NOT PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD FOUND THE BELOW WHICH COULD BE RELATED TO THE REPORTED EVENT: THERE WAS A PREVIOUS CORRECTIVE MAINTENANCE ON THE SAME DEVICE DURING WHICH THE FSE FOUND THE CPU BOARD OF THE CONTROLLER NEEDED TO BE REPLACED. THIS ISSUE IS REFERENCED IN (B)(4), THE CPU BOARD ON THE ROSE ONE SYSTEM WAS MALFUNCTIONING SO A LOANER UNIT WAS USED IN THE FIELD UNTIL INVESTIGATION/REPAIR COULD BE COMPLETED. (B)(4) IS THE CORRECTIVE MAINTENANCE ON THIS CPU. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem · 0

IT WAS REPORTED DURING CORRECTIVE MAINTENANCE, CONTROLLER WILL NOT CONNECT TO COMPUTER. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1159180	ROSA ONE BRAIN	COMPUTER-ASSISTED SURGICAL DEVICE	HAW	MEDTECH SAS	N/A	N/A	03760244032492

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown