FDA Adverse Event
Injury
Summary report: N
2023050-2017-05005
MDR report key: 6347100
·
Received February 21, 2017
Report
- Report Number
- 2023050-2017-05005
- Event Type
- Injury
- Date Received
- February 21, 2017
- Report Date
- January 26, 2017
- Manufacturer
- COSTA MESA MFG DC
- Product Code
- CBK
- PMA / PMN Number
- K111146
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE VENTILATOR WAS EVALUATED AND THE OXYGEN MIXER WAS REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PATIENT USE, THE VENTILATOR'S OXYGEN READINGS READ HIGHER THAN SET VALUES. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON A SECOND VENTILATOR. VENTILATION WAS NOT INTERRUPTED. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 127833 | CBK | COSTA MESA MFG DC | HT70P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |