SERVO-I
Received Aug 23, 2022 · Event occurred Jul 28, 2022
Report 8010042-2022-01460 · MDR key 15274916
Device
Product problems
- Fracture
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM HOLDING THE PATIENT CIRCUIT WAS BROKEN. PATIENT INVOLVEMENT IS UNKNOWN. MANUFACTURER'S REF #: (B)(4).
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE SUPPORT ARM HOLDING THE PATIENT CIRCUIT WAS BROKEN. IDENTIFICATION OF ISSUE HAS BEEN DONE BY ANALYZING PROBLEM DESCRIPTION, SERVICE REPORT AND COMMUNICATION WITH FIELD SERVICE TECHNICIAN (FSE). INVESTIGATED COMPLAINT WAS DECIDED TO BE REPORTED BASED ON AVAILABLE INFORMATION (NO INFORMATION ABOUT WHICH PART OF SUPPORT ARM WAS BROKEN), AS THE INITIAL DESCRIPTION MIGHT HAVE UNDERLYING CAUSES WHICH REPRESENT A REPORTABLE EVENT. IN THE FURTHER PROCESS OF COMPLAINT HANDLING THE ISSUE WAS RELATED WITH BROKEN FLEXIBLE ROD. THIS ISSUE WILL BE NOTICED DURING SETUP AND APPROPRIATE MEASURES TAKEN. THERE WAS NO PATIENT HARM. THE ROOT CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED. THE CORRECTION OF THE FIELD USAGE OF DEVICE WAS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS USAGE OF DEVICE: UNKNOWN. CORRECTED USAGE OF DEVICE: REUSE.
Description of Event or Problem
MANUFACTURER'S REF #: (B)(4).