FDA Adverse Event
Malfunction
Summary report: N
GE CARESTATION 650 ANESTHESIA MACHINE
MDR report key: 22809992
·
Received August 14, 2025
Report
- Report Number
- MW5174581
- Event Type
- Malfunction
- Date Received
- August 14, 2025
- Date of Event
- December 26, 2024
- Report Date
- August 12, 2025
- Manufacturer
- GE HEALTHCARE TECHNOLOGIES INC.
- Product Code
- BSZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
GE CARESTATION 650 ADJUSTABLE PRESSURE LIMITING VALVE WOULD NOT RELEASE AIRWAY PRESSURE WHEN PATIENT IS SPONTANEOUSLY BREATHING, AND ADJUSTABLE PRESSURE LIMITING VALVE SET AT MINIMUM. CLINICIAN HAD TO REMOVE REBREATHING BAG FROM PATIENT TO RELEASE THE POSITIVE AIRWAY PRESSURE ON BREATHING CIRCUIT. A SERVICE CALL FOR GE SERVICE WAS PLACED AND GE FIELD ENGINEER FOUND THE ADJUSTABLE PRESSURE LIMITING VALVE DIAPHRAGM WAS WORN OUT. REPLACED DIAPHRAGM ASSEMBLY, ADJUSTABLE PRESSURE LIMITING BREATHING CIRCUIT GAS WAS ORDERED AND REPLACED. FULL CHECKOUT AND TEST PROCEDURES WERE COMPLETED PER MANUFACTURE SPECIFICATIONS. SYSTEM RETURNED TO SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2788695 | GE CARESTATION 650 ANESTHESIA MACHINE | GAS-MACHINE, ANESTHESIA | BSZ | GE HEALTHCARE TECHNOLOGIES INC. | CARESTATION 650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |