MULTIX PRO
Received Apr 12, 2019 · Event occurred Jul 31, 2018
Report 3004977335-2018-42768 · MDR key 8510799
Device
Product problems
- Use of Device Problem
- Adverse Event Without Identified Device or Use Problem
- Use of Device Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Injury
- Injury
Narrative
Additional Manufacturer Narrative
**RESUBMISSION OF INITIAL REPORT AS PER FDA ON 4/3/19** THE DESCRIBED ISSUE WAS INVESTIGATED BASED ON THE INFORMATION PROVIDED BY THE SERVICE ENGINEER ON THE SITE; THE RETURNED COMPLAINT PART (PATIENT HANDGRIP, MATERIAL NUMBER 1292379) WAS EXAMINED. PRIOR TO THE DESCRIBED EVENT THE CUSTOMER HAD REPAIRED THE PATIENT HANDGRIP WITHOUT INVOLVING AUTHORIZED SERVICE PERSONNEL. HEREBY, THE SNAP RING THAT HOLDS A SPRING IN PLACE FOR PROPER AXEL MOVEMENT WAS NOT POSITIONED CORRECTLY. AS A CONSEQUENCE THE HANDGRIP DID NOT SWITCH INTO OPERATIONAL POSITION AND REMAINED MOVABLE. WHEN THE PATIENT GRASPED THE HANDGRIP, IT SWUNG DOWN AND HIT THE PATIENT. THE REASON FOR THE INITIAL DEFECT OF THE PART CANNOT BE DETERMINED. THE DAMAGE FOUND ON THE SNAP RING MAY BE CAUSED BY IMPROPER USE OF THE HANDGRIP. NO MATERIAL FAILURE WAS IDENTIFIED AND NO GENERAL PROBLEM IS KNOWN REGARDING THIS COMPONENT. AT THE CONCERNED CUSTOMER SYSTEM THE HANDGRIP WAS REPLACED BY A SERVICE TECHNICIAN. THE CUSTOMER WAS ADVISED THAT ACCORDING TO SAFETY INSTRUCTIONS ANY SYSTEM REPAIR MUST BE PERFORMED BY QUALIFIED AND AUTHORIZED PERSONNEL ONLY.
Additional Manufacturer Narrative
THE CAUSE OF THE INCIDENT IS ASSESSED AS INDIVIDUAL WORKMANSHIP ERROR OF THE USER TRYING TO PERFORM SERVICE ON THE SYSTEM.
Description of Event or Problem
SIEMENS BECAME AWARE OF AN ADVERSE EVENT WITH THE MULTIX PRO SYSTEM. THE USER HAD PERFORMED A REPAIR OF THE PATIENT HANDGRIP AND INCORRECTLY PLACED A SNAP RING THAT LOCKS THE HAND GRIP IN POSITION. THE REPAIR WORK WAS DONE WITHOUT SIEMENS' INVOLVEMENT. THE REPAIR WAS PERFORMED INCORRECTLY; HOWEVER, THE USER RELEASED THE UNIT FOR REGULAR CLINICAL OPERATION. DURING AN EXAMINATION, A PATIENT HANDLE THAT IS SUPPOSED TO BE FIRMLY FITTED BECAME LOOSE AND HIT PATIENT'S HEAD WHEN SHE TRIED TO GRAB IT. ACCORDING TO THE USER, THE PATIENT REQUIRED STAPLES TO STITCH THE WOUND. NO OTHER DETAILS WERE PROVIDED.