FDA Adverse Event
Injury
Summary report: N
CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM
MDR report key: 23816390
·
Received December 16, 2025
Report
- Report Number
- 3024985933-2025-00041
- Event Type
- Injury
- Date Received
- December 16, 2025
- Date of Event
- November 27, 2024
- Report Date
- December 16, 2025
- Manufacturer
- ENDOTRONIX, INC
- Product Code
- MOM
- UDI-DI
- 00850008997006
- PMA / PMN Number
- P230040
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION WILL BE SUBMITTED VIA FOLLOW-UP REPORT WITHIN 30 DAYS OF RECEIPT.
Description of Event or Problem · 0
ON (B)(6) 2023, PRIOR TO DEVICE COMMERCIALIZATION, ENDOTRONIX (ETX) SUSPECTED SENSOR INACCURACY WAS IDENTIFIEDS DURING PROACTIVE MONITORING AND RECOMMENDED AN UNSCHEDULED RECALIBRATION; HOWEVER, THE SITE WAS UNRESPONSIVE. MULTIPLE RECALIBRATION RECOMMENDATIONS WERE ISSUED THROUGHOUT 2024, AND THE PATIENT LATER UNDERWENT AN UNSCHEDULED RECALIBRATION ON (B)(6) 2024, WITH RESULTS OUTSIDE THE FLUID FILLED LIMITS OF AGREEMENT (FFLOA). AS OF (B)(6) 2025, THE PATIENT IS CLINICALLY STABLE AND TAKING READINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1875988 | CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM | PULMONARY ARTERY SENSOR | MOM | ENDOTRONIX, INC | E220308-01 | 00850008997006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Male | Other |