FDA Adverse Event
Malfunction
Summary report: N
MERGE
MDR report key: 23154006
·
Received September 26, 2025
Report
- Report Number
- 23154006
- Event Type
- Malfunction
- Date Received
- September 26, 2025
- Date of Event
- September 15, 2025
- Report Date
- September 18, 2025
- Manufacturer
- MERGE HEALTHCARE SOLUTIONS, INC
- Product Code
- DQK
- 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
WHILE PATIENT ON THE CATH LAB TABLE, MERGE HEMODYNAMICS SOFTWARE BECAME DISCONNECTED TO PDM [PATIENT DATA MODULE] CAUSING HEMODYNAMICS SCREEN TO TURN BLACK. UNABLE TO MONITOR PATIENT'S VITALS WHILE PATIENT WAS ON THE TABLE. THIS HAPPENED TWICE DURING THE CASE. PATIENT PLACED ON SECONDARY DEFIB MONITOR WHILE SYSTEM WAS REBOOTED. REBOOTING SYSTEM FIXES PROBLEM. REPORTED TO MERGE VENDOR, TICKET # RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2124533 | MERGE | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | DQK | MERGE HEALTHCARE SOLUTIONS, INC | PB-1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Male |