LUNAR PRODIGY
Received Sep 11, 2014 · Event occurred Nov 5, 2013
Report 2112667-2014-00107 · MDR key 4106644
Device
Manufacturer
Datex-ohmeda Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Injury
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE THE SCAN ARM OF A LUNAR PRODIGY SYSTEM WAS POSITIONING GOING FROM A SPINE EXAM TO A FEMUR EXAM, THE ARM CAME INTO CONTACT WITH THE PATIENT'S LEFT THIGH. THE TECHNOLOGIST IMMEDIATELY LOOKED AT THE PATIENT'S LEG AND OBSERVED BRUISING. THE PATIENT ALSO SUSTAINED MENISCUS DAMAGE ON THE KNEE.
Additional Manufacturer Narrative
THE INITIAL REPORT WAS FILED ON (B)(4) 2013 UNDER THE INCORRECT MANUFACTURING SITE (B)(4). THE CORRECT MANUFACTURING SITE IS DATEX-OHMEDA, (B)(4). (B)(4) INVESTIGATION HAS BEEN COMPLETED, THE HOSPITAL'S DIRECTOR OF IMAGING CONFIRMED THAT THE SCAN ARM WAS MOVING INTO POSITION TO SCAN THE FEMUR AND WAS NOT IN SCAN MODE AT THIS TIME. SHE ALSO CONFIRMED THE COLLISION OCCURRED DUE TO THE PATIENT'S LEGS NOT BEING FLAT AS REQUIRED DURING THE SCAN, THEREFORE, THE MOST PROBABLE ROOT CAUSE WAS USE ERROR. AFTER FURTHER DISCUSSION WITH THE SITE'S DIRECTOR OF RISK MANAGEMENT, SHE CONFIRMED THAT THEY ARE NOT AWARE OF ANY MEDICAL ATTENTION, INTERVENTION, NOR TESTS FOR THE PATIENT. THEY HAVE NO CONFIRMATION OF ANY DIAGNOSIS; AND THE PATIENT HAS NOT HAD ANY VISITS TO THE SITE SINCE THE EVENT. THERE ARE ADEQUATE INSTRUCTIONS AND MITIGATIONS IN PLACE ON HOW TO PROPERLY POSITION THE PATIENT (USER MANUAL PART NUMBER LU43616EN REV. 14). NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.