MalfunctionMDC
INTELLIBRIDGE SYSTEM
Received Dec 21, 2021 · Event occurred Dec 10, 2021
Report 1218950-2021-11198 · MDR key 13055146
Device
Generic name
Intellibridge System
Manufacturer
Philips North America LlcModel number
866417Catalog number
866417
Product problems
- Incorrect Measurement
- Incorrect Measurement
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT INCORRECT VALUES WERE BEING TRANSMITTED BY THEIR INTELLIBRIDGE SYSTEM EC40.THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.
Additional Manufacturer Narrative
A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION
Description of Event or Problem
THE CUSTOMER REPORTED THAT INCORRECT VALUES WERE BEING TRANSMITTED BY THEIR INTELLIBRIDGE SYSTEM EC40. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.