INVIVO
Received Feb 21, 2023 · Event occurred Nov 16, 2022
Report 1056069-2023-00001 · MDR key 16407311
Device
Generic name
Sentinelle Breast Coil
Manufacturer
Invivo CorporationModel number
SENTINELLE SMS SKYRA 3T 8CH BREAST COILCatalog number
453530384591
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
73 YR · Female
- Multiple Fractures
- Multiple Fractures
Narrative
Additional Manufacturer Narrative
THIS INCIDENT WAS ALREADY REPORTED TO THE FDA BY SIEMENS UNDER 3002808157-2022-54760. AS THE MANUFACTURER OF THE COIL THAT WAS USED AT THE TIME OF THE INCIDENT PHILIPS HAS ALSO DECIDED TO INFORM THE FDA OF THIS INCIDENT. HOWEVER, FROM THE INFORMATION RECEIVED FROM SIEMENS IT IS CLEAR THAT THE INCIDENT WAS CAUSED BY A MALFUNCTION OF THE PATIENT TABLE OF THE SIEMENS MR SYSTEM WHERE THE COIL WAS USED IN. PHILIPS WILL THEREFORE PERFORM NO FURTHER INVESTIGATION INTO THIS INCIDENT.
Description of Event or Problem
PHILIPS RECEIVED A REPORT FROM A 3RD PARTY CUSTOMER, (B)(6) GMBH MR, THAT A PATIENT SUFFERED MULTIPLE RIB FRACTURES WHILST BEING EXAMINED ON AN MAGNETOM SYMPHONY A TIM USING A SENTINELLE BREAST COIL.