FDA Adverse Event
Malfunction
Summary report: N
MERGE HEMO PDM
MDR report key: 24291625
·
Received February 9, 2026
Report
- Report Number
- 24291625
- Event Type
- Malfunction
- Date Received
- February 9, 2026
- Date of Event
- January 22, 2026
- Report Date
- January 29, 2026
- Manufacturer
- SCHILLER AMERICAS, INC.
- Product Code
- MHX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
MERGE HEMODYNAMIC SYSTEM NOT WORKING AS DESIGNED, UNABLE TO WORK IN CATH LAB ROOM #4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351209 | MERGE HEMO PDM | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | SCHILLER AMERICAS, INC. | PB-1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Male |