FDA Adverse Event
Malfunction
Summary report: N
CARDELLA¿ PULMONARY ARTERY SENSOR SYSTEM
MDR report key: 23108775
·
Received September 22, 2025
Report
- Report Number
- 3024985933-2025-00033
- Event Type
- Malfunction
- Date Received
- September 22, 2025
- Date of Event
- August 29, 2025
- Report Date
- November 25, 2025
- Manufacturer
- ENDOTRONIX, INC
- Product Code
- MOM
- PMA / PMN Number
- P230040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
UPON FURTHER REVIEW, THE EVENT DOES NOT MEET REPORTING CRITERIA AND IS NOT CONSIDERED REPORTABLE. NO DEVICE MALFUNCTION OR ADVERSE EVENT WAS IDENTIFIED. NO FURTHER INVESTIGATION IS REQUIRED.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION WILL BE SUBMITTED VIA FOLLOW-UP REPORT WITHIN 30 DAYS OF RECEIPT.
Description of Event or Problem · 0
THE PATIENT'S DATA WAS REVIEWED BY ENDOTRONIX'S INTERNAL MONITORING PROGRAM AND SUSPECTED SENSOR INACCURACY WAS IDENTIFIED. THE SITE HAS BEEN INFORMED TO SCHEDULE A RECALIBRATION. THE PATIENT IS CURRENTLY PENDING A RIGHT HEART CATHETERIZATION (RHC) AND SENSOR RECALIBRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2535130 | CARDELLA¿ PULMONARY ARTERY SENSOR SYSTEM | PULMONARY ARTERY SENSOR | MOM | ENDOTRONIX, INC | 100303-05 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |