FDA Adverse Event
Malfunction
Summary report: N
IACS
MDR report key: 15595866
·
Received October 12, 2022
Report
- Report Number
- MW5112586
- Event Type
- Malfunction
- Date Received
- October 12, 2022
- Report Date
- October 10, 2022
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC.
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
PARAMETER VALIDATION WAS NEVER CONDUCTED. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2175929 | IACS | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | DRAEGER MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |