PRODUCT VYNTUS BODY
Received Sep 27, 2023 · Event occurred May 11, 2023
Report 9615102-2023-00141 · MDR key 17827558
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
ON (B)(6) 2023 DURING A COMPLAINT SEARCH IT BECAME EVIDENT, THAT THIS COMPLAINT IS A SIMILAR COMPLAINT TO THE REPORTABLE COMPLAINT (B)(4). THE REPORTING DECISION WAS UPDATED ACCORDINGLY. THE CUSTOMER CALLED AND COMPLAINED THAT THE US SENSOR EASILY BECOMES LOOSE AND COULD FALL DOWN IN CASE A PATIENT TOUCHES IT UNINTENTIONAL. DURING REMOTE TROUBLESHOOTING NO FINAL CAUSE COULD BE IDENTIFIED. THE SENSOR WAS NOT SENT BACK FOR INVESTIGATION. THE US SENSOR WAS REPLACED DURING A STANDARD MAINTENANCE AT CUSTOMERS SITE. THE CAPA INVESTIGATION IDENTIFIED THE FOLLOWING ROOT CAUSE: MISUSE OF THE USS AS A ¿HANDLE¿ TO CHANGE THE SUPPORT ARM POSITION INSTEAD OF USING THE PROPER HANDLE OF THE VYNTUS BODY SUPPORT ARM OR THE SUPPORT ARM ITSELF. THIS MISUSE LOOSENS THE MECHANICAL CONNECTION BETWEEN THE USS AND THE FPV SO IT BECOMES INSUFFICIENT TO HOLD THE USS IN PLACE.
Description of Event or Problem
THE CUSTOMER COMPLAINED THAT THE US SENSOR DETACHES EASILY. NO PATIENT INJURIES HAPPENED.