SENSE BREAST 3.0T
Received Jan 31, 2014
Report 1056069-2014-00001 · MDR key 3750732
Device
Product problems
- Entrapment of Device
Patient
Not reported
- Bone Fracture(s)
- Pain
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT DURING A TEST OF AN MRI BREAST PROTOCOL WITH THE NEW MAMMOCOIL ON THE PHILIPS PET/MRI, A PATIENT WAS POSITIONED ON THE COIL AND THE TABLE WAS MOVED INTO THE MRI TUNNEL USING THE "TRAVEL TO SCANPLANE" BUTTON. DURING THE MOVEMENT OF THE TABLE TO THE SCANNING POSITION, THE PATIENT BECAME TRAPPED BETWEEN THE COIL AND THE TOP OF THE BORE. THE PATIENT INDICATED PAIN AND WAS IMMEDIATELY REMOVED FROM THE BORE. A FEW DAYS LATER THE PATIENT WAS DIAGNOSED WITH A BROKEN RIB.
Additional Manufacturer Narrative
(B)(4): EVAL METHOD: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA. EVAL RESULTS: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA. CONCLUSION: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA.