InjuryPCK
BERLIN HEART EXCOR DEVICE
Received Nov 29, 2016 · Event occurred Nov 23, 2016
Report MW5066380 · MDR key 6135036
Device
Product problems
- Defective Device
Patient
2 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DEFECT IN BERLIN HEART MACHINE, REQUIRING PATIENT TO UNDERGO SURGERY TO HAVE MACHINE SWAPPED OUT. DATES OF USE: (B)(6) 2016. REASON FOR USE: DILATED CARDIOMYOPATHY.