MalfunctionPCK
BERLIN HEART
Received Mar 9, 2020 · Event occurred Dec 16, 2019
Report 9805365 · MDR key 9805365
Device
Product problems
- Noise, Audible
Patient
270 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
OUR PATIENT WITH A BERLIN HEART HAD A PUMP THAT WAS MAKING A CRUNCHING NOISE. VIDEO AND PICTURE OF THE PUMP WERE TAKEN AND SENT TO BERLIN HEART TO ASSESS. INITIALLY WE WERE TOLD THAT NO INTERVENTIONS WERE NEEDED. THE FOLLOWING DAY, WE RECEIVED A CALL FROM BERLIN HEART AND WERE TOLD THAT AFTER THEY FURTHER ASSESSED THE VIDEO AND IMAGES OF THE PUMP, WE SHOULD CHANGE IT OUT. SO THE PUMP WAS EXCHANGED WITH NO ISSUES OR HARM TO THE PATIENT.