FDA Adverse Event
Malfunction
Summary report: N
CARESTATION 650
MDR report key: 25299339
·
Received May 27, 2026
Report
- Report Number
- 2112667-2026-03539
- Event Type
- Malfunction
- Date Received
- May 27, 2026
- Date of Event
- April 28, 2026
- Report Date
- May 27, 2026
- Manufacturer
- DATEX-OHMEDA, INC.
- Product Code
- BSZ
- UDI-DI
- 00840682103947
- PMA / PMN Number
- K151570
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE ANESTHESIA CONTROL BOARD WAS REPLACED TO RESOLVE THE ISSUE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LAN ERROR THAT RESULTS IN AN INABILITY TO INITIATE MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324629 | CARESTATION 650 | ANESTHESIA GAS MACHINE | BSZ | DATEX-OHMEDA, INC. | A1 | NA | 00840682103947 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |