ZERO GRAVITY CONTOUR TRACK SYSTEM
Received Jan 27, 2023
Report 2182318-2023-00001 · MDR key 16259759
Device
Product problems
- Contamination /Decontamination Problem
- Detachment of Device or Device Component
- Contamination /Decontamination Problem
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
MONORAIL SCREW COVERS FALLING INTO STERILE FIELD. MODEL: ZGCH. SERIAL#: (B)(4). MANUFACTURED 2013.
Additional Manufacturer Narrative
DEVICE EVALUATED BY MFR: DEVICE EVALUATION IS EXPECTED, BUT NOT YET PERFORMED. THIS EVENT WAS INITIALLY REPORTED TO THE DISTRIBUTOR, BIOTRONIK. IT WAS REPORTED THAT THE SCREW COVERS ON THE RAIL WERE FALLING INTO THE STERILE FIELD. THERE WAS NO PATIENT OR CAREGIVER INJURY REPORTED AS A RESULT OF THIS EVENT. THE UNIT HAS BEEN TAKEN OUT OF USE, CURRENTLY. THIS IS THE FIRST REPORTED COMPLAINT OF THIS TYPE, BASED ON HISTORICAL COMPLAINT DATA REVIEW. THE SCREW COVERS ARE SPECIFIC TO THIS ZERO GRAVITY MODEL, WHICH HAS BEEN DISCONTINUED. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. THE ORIGINAL MALFUNCTIONING COMPONENT IS BEING REQUESTED TO BE RETURNED FOR EVALUATION, BUT HAS NOT BEEN RECEIVED. DEVICE EVALUATION BY THE TECHNICIAN FOR SERVICING HAS NOT YET BEEN COMPLETED. PER THE INSTRUCTIONS FOR USE (IFU) ¿A THOROUGH INSPECTION OF EQUIPMENT SHOULD BE PERFORMED, AFTER EACH SERVICE CALL, PRIOR TO RELEASING THE EQUIPMENT FOR USE.¿ ADDITIONALLY, ¿THE ZERO-GRAVITY SYSTEM REQUIRES ANNUAL PREVENTATIVE MAINTENANCE, INSPECTION, AND GENERAL CLEANING THROUGHOUT ITS LIFE.¿ MANUFACTURER REFERENCE FILE (B)(4).