FDA Adverse Event
Malfunction
Summary report: N
AISYS
MDR report key: 21086524
·
Received January 6, 2025
Report
- Report Number
- 2112667-2025-00113
- Event Type
- Malfunction
- Date Received
- January 6, 2025
- Date of Event
- December 9, 2024
- Report Date
- February 11, 2025
- Manufacturer
- DATEX-OHMEDA, INC.
- Product Code
- BSZ
- UDI-DI
- 00840682102292
- PMA / PMN Number
- K172045
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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 CARRIER COM EXPRESS 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.
Additional Manufacturer Narrative · 0
THE INITIAL MDR 2112667-2025-00113 WAS SUBMITTED ERRONEOUSLY INDICATING IT WAS A 5-DAY, INITIAL MDR IN BLOCK G6. THIS SUPPLEMENTAL 2112667-2025-00113 #1 IS BEING TO SUBMITTED TO CORRECT THE ERROR. THE INITIAL MDR SHOULD HAVE INDICATED 30-DAY INITIAL MDR. BLOCK G6 HAS BEEN CORRECTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS AN ERROR CAUSING AN INABILITY TO INITIATE MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360173 | AISYS | ANESTHESIA GAS MACHINE | BSZ | DATEX-OHMEDA, INC. | CS2 | NA | 00840682102292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |