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