SERVO-I
Received Sep 6, 2021 · Event occurred Aug 11, 2021
Report 8010042-2021-02167 · MDR key 12427644
Device
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS CLAIMED THAT THE REPAIR OF SUPPORT ARM IS REQUESTED. IDENTIFICATION OF ISSUE HAS BEEN DONE BY ANALYZING PROBLEM DESCRIPTION. THERE WAS NO PATIENT HARM. BASED ON THE INFORMATION COLLECTED TO DATE, IT HAS BEEN CLARIFIED THAT CLAMP MOUNT HAS BEEN DAMAGED BY WEAR CAUSED BY USE. THE CLAMP MOUNT IS A PART OF SUPPORT ARM AND IS MOUNTED DIRECTLY TO THE SERVO DEVICE. THE SUPPORT ARM SERVES TO RELIEVE THE PATIENT FROM THE WEIGHT OF THE TUBING SYSTEM. WHEN MOVING THE SUPPORT ARM OR CHANGING POSITION, THE PATIENT CONNECTION SHOULD BE OBSERVED TO SEE THAT NO PULLING OR OTHER MOVEMENT OCCURS. THE ISSUE WAS DECIDED TO BE REPORTED AS BROKEN/DAMAGED SUPPORT ARM MAY LEAD TO STOP OF VENTILATION (EXTUBATION) OR INJURY. THE ROOT CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED. THE CORRECTION OF FIELDS #H4 DEVICE MANUFACTURE DATE AND #H8 USAGE OF DEVICE WAS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. #H4 MANUFACTURE DATE: PREVIOUS MANUFACTURE DATE: 03/26/2017. CORRECTED MANUFACTURE DATE: 03/20/2017. #H8 USAGE OF DEVICE: PREVIOUS USAGE OF DEVICE: UNKNOWN. CORRECTED USAGE OF DEVICE: REUSE.
Description of Event or Problem
MANUFACTURER'S REF. #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM WAS BROKEN. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).