FDA Adverse Event
Malfunction
Summary report: N
CURAPLEX
MDR report key: 20382998
·
Received October 7, 2024
Report
- Report Number
- 20382998
- Event Type
- Malfunction
- Date Received
- October 7, 2024
- Date of Event
- July 23, 2024
- Report Date
- August 22, 2024
- Manufacturer
- BOUND TREE MEDICAL, LLC
- Product Code
- CCW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
A LARYNGOSCOPE FROM THE ANESTHESIA CART WAS PULLED YESTERDAY FOR A PATIENT THAT WE HAD TO EMERGENTLY INTUBATE. THE LARYNGOSCOPE WAS NOT FUNCTIONING PROPERLY, IT DID NOT LIGHT UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268352 | CURAPLEX | LARYNGOSCOPE, RIGID | CCW | BOUND TREE MEDICAL, LLC | 301-LED-030S | 210927D0326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose |