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