CONNEXION IMAGING MODULE
Received Apr 10, 2018
Report 9710332-2018-00001 · MDR key 7410597
Device
Generic name
System, Planning, Radiation Therapy Treatment
Manufacturer
Medical Intelligence Medizintechnik GmbhModel number
P10105-210Catalog number
P10105-210
Lot number
P10105-210
Product problems
- Device Issue
- Break
- Device Issue
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.
Description of Event or Problem
THE CUSTOMER REPORTED WHILST POSITIONING A PATIENT, THE MIDDLE SECTION OF THE TABE TOP BROKE.
Additional Manufacturer Narrative
THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE BROKEN IMAGING MODULE WAS SENT TO THE SUPPLIER FOR ROOT CAUSE ANALYSIS, HOWEVER THE BREAKAGE COULD NOT BE DETERMINED. THE RISK ASSESSMENT AND THE DYNAMIC AND STATIC OVERLOAD TESTS CONCLUDE THAT THE CURRENT DESIGN IS SAFE AND NO FAILURES IN THE MANUFACTURING PROCESS CAN BE DETECTED. THE FRACTION PATTERN HOWEVER, INDICATES A POTENTIAL EARLIER DYNAMIC OVERLOAD WHICH MIGHT HAVE PREDAMAGED THE BOARD AND MOST LIKELY OCCURRED IN THE FIELD AFTER INSTALLATION.