FDA Adverse Event
Death
Summary report: N
BRITEPRO SOLO SINGLE USE FIBRE OPTIC LARYNGOSCOPE
MDR report key: 16973969
·
Received May 22, 2023
Report
- Report Number
- 3006061749-2023-00013
- Event Type
- Death
- Date Received
- May 22, 2023
- Date of Event
- February 14, 2023
- Report Date
- February 13, 2023
- Manufacturer
- FLEXICARE MEDICAL LTD
- Product Code
- CCW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
EVENT OCCURED AS DESCRIBED BY COMPLAINANT BELOW - "THE LIGHT DIDNT WORK DURING A CARDIAN ARREST, THESE ARE ON ALL OUR RESUSCITATION CARTS. WE CHECKED IN CERU AND FOUND THAT SOME FAILED AS WELL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 808473 | BRITEPRO SOLO SINGLE USE FIBRE OPTIC LARYNGOSCOPE | LARYNGOSCOPE | CCW | FLEXICARE MEDICAL LTD | 200700764 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |