MAUDE Adverse Event Report: BOMIMED INC BOMIMED DISPOSABLE MEDIUM LED LARYNGOSCOPE HANDLE; DISPOSABLE MEDIUM LARYNGOSCOPE HANDLE

Model Number MEDIUM, LED

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2022

Event Type  malfunction  

Manufacturer Narrative

The occurrence involved a bomimed handle and a blade from a different company, which is not controlled by bomimed.The devices were both disposed of and not returned, therefore unable to complete an investigation and determine a root cause.

Event Description

Relating to the failure of the laryngoscope blade to remain attached to the laryngoscope handle.Attempting to perform direct laryngoscopy, the laryngoscope blade was clicked on to the handle in the down, standby position.When brought up to click into the handle and engage the light for use, the blade would slide out and pop off the handle.This happened more than three times when attempting to use the device.The solution was to attach the handle between 45 and 90 degrees, then maintain back pressure when swinging up into place.It seemed that the bumps used to lock the blade in to place, dislodged the blade forward off of the handle if back pressure was not being applied.The issue occurred when checking the device for use before intubation attempt, when attempting intubation, and on the second intubation attempt.This did not greatly affect patient care, however did require two dedicated hands to keep the device together when moving from standby to in action.Once the blade was engaged, there were no problems.The affected devices were disposed of.

• Brand Name: BOMIMED DISPOSABLE MEDIUM LED LARYNGOSCOPE HANDLE
• Type of Device: DISPOSABLE MEDIUM LARYNGOSCOPE HANDLE
• Manufacturer (Section D): BOMIMED INC; 1-100 irene street; winnipeg, manitoba R3T 4 E1; CA R3T 4E1
• Manufacturer (Section G): SCOPE MEDICAL DEVICES PRIVATE LIMITED; survey number 11/10; jaraut road, village mandhour; ambala city, haryana 13400 3; IN 134003
• Manufacturer Contact: trina friesen ; 1-100 irene street; winnipeg, manitoba R3T 4-E1 ; CA R3T 4E1
• MDR Report Key: 15628265
• MDR Text Key: 304795131
• Report Number: 3003213883-2022-00001
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEDIUM, LED
• Device Catalogue Number: OL-334L6
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention