MAUDE Adverse Event Report: SUNMED SUNMED; F/O GREENLINE D MAC SIZE 3

Model Number 5-5332-03

Device Problems Product Quality Problem (1506); Defective Component (2292)

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

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

The defect caused the patient to have a delay in the intubation procedure.There was no patient injury, this incident will be reported.Intubation was hindered which delays in establishing a protected airway.Which increases the risk to the patient.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.

Event Description

I had a dr call me in the room today, put it in the pts mouth and i couldn't see anything.It was a black hole.The light that is coming out of these blades is horrible.

Event Description

I had a dr call me in the room today, put it in the pts mouth and i couldn't see anything.It was a black hole.The light that is coming out of these blades is horrible.

Manufacturer Narrative

The defect caused the patient to have a delay in the intubation procedure.There was no patient injury, this incident will be reported.Intubation was hindered which delays in establishing a protected airway.Which increases the risk to the patient.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.Because the problematic blades were not returned, we were unable to confirm the complaint.However, by collecting available samples of the same p/n, we were able to replicate the intubrite handle and sunmed blade combination.When testing, the sunmed blade light up just as easily as the intubrite blade.When light output was measured, the sunmed blade was even higher than the intubrite.The issue the customer had with their sunmed blade could have been because of user preference and experience with only the intubrite blades.The risk analysis (rma-20002b) presented r20 as a comparable risk id.This risk item has a severity of 7 = extreme, but is below an 8 and is not required for review at carb.Reportable because of delayed intubation attempts and placement of the laryngoscope.No patient harm was reported.

• Brand Name: SUNMED
• Type of Device: F/O GREENLINE D MAC SIZE 3
• Manufacturer (Section D): SUNMED; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 13239466
• MDR Text Key: 287581182
• Report Number: 1314417-2022-00001
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5-5332-03
• Device Lot Number: 21K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other