VITAL SYNC
Received Jul 8, 2025
Report 1717344-2025-00886 · MDR key 22438420
Device
Generic name
Transmitters And Receivers, Physiological Sign
Manufacturer
Covidien Mfg Dc BoulderModel number
VITALSYNCSW03Catalog number
VITALSYNCSW03
Product problems
- Computer System Security Problem
- Computer System Security Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO USE, A VULNERABILITY WITH THE REMOTE SURVEILLANCE CYBERSECURITY PLATFORM WAS IDENTIFIED, AND THE CYBER SECURITY PLATFORM ISSUED AN ALERT REGARDING THIS VULNERABILITY ON ALL EIGHT SERVERS SERVING THE SITE. THE SITE DETERMINED THAT THE PROGRAM NEEDED TO BE UPDATED TO THE MOST CURRENT VERSION TO REDUCE THE VULNERABILITY. THERE WAS NO PATIENT INVOLVEMENT.