S3 BUBBLE DETECTOR
Received Dec 18, 2018 · Event occurred Nov 20, 2018
Report 9611109-2018-01410 · MDR key 8173123
Device
Generic name
Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass
Manufacturer
Livanova DeutschlandModel number
23-07-50Product problems
- Sensing Intermittently
- Appropriate Device Problem Term/Code Not Available
- Sensing Intermittently
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
SERIAL NUMBER WAS NOW GIVEN.
Description of Event or Problem
SEE INITIAL REPORT.
Description of Event or Problem
SEE INITIAL.
Additional Manufacturer Narrative
THE EVENT HAS BEEN RE-EVALUATED AS NOT REPORTABLE. THE HIGHER SENSITIVITY OF THE SENSOR COULD CAUSE FALSE ALARM, WITHOUT ANY RISK FOR THE PATIENT. MOREOVER, THIS CAN ALWAYS BE IDENTIFIED PRIOR TO PATIENT USE.
Additional Manufacturer Narrative
PATIENT INFORMATION WAS NOT PROVIDED. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. LIVANOVA DEUTSCHLAND MANUFACTURES THE S3 BUBBLE DETECTOR. THE INCIDENT OCCURRED IN (B)(4). IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE SENSITIVITY OF A S3 BUBBLE DETECTOR BECAME UNSTABLE AND ERROR MESSAGE OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY.
Remedial action
- Other