FDA Adverse Event
Malfunction
Summary report: N
CARESCAPE
MDR report key: 20859525
·
Received December 5, 2024
Report
- Report Number
- 2112667-2024-06508
- Event Type
- Malfunction
- Date Received
- December 5, 2024
- Date of Event
- November 7, 2024
- Report Date
- December 5, 2024
- Manufacturer
- DATEX-OHMEDA, INC.
- Product Code
- CBK
- UDI-DI
- 00840682102346
- PMA / PMN Number
- K210384
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE ELECTRONIC FLOW CONTROL (EFC) VALVE 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 INSUFFICIENT OXYGEN OR FRESH GAS FLOW. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1377384 | CARESCAPE | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | DATEX-OHMEDA, INC. | R860 | NA | 00840682102346 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |