MAUDE Adverse Event Report: SALTER LABS; BX20 - PEDIATRIC DISPOSABLE HANDLE 2/BATTERY & BX20 - MILLER 00 DISPOSABLE LED B

Model Number 2016.C & 1039.C

Device Problem Electrical Power Problem (2925)

Patient Problem Insufficient Information (4580)

Event Date 07/19/2021

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.One handle had very dim lighting and another had no light at all.The blades and handles were determined to be the issue for the delayed intubation in a critical situation.Low illumination may delay intubation's or increase the number of failed attempts.Standard practice is that a laryngoscope be checked for proper illumination prior intubation.Limited or no illumination could compromise intubation or first pass success rate.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.

Event Description

Light going out during an intubation attempt.

Event Description

Light going out during an intubation attempt.

Manufacturer Narrative

Product did not return, and a formal investigation into the failure mode could not be completed.The complaint could not be confirmed without returned product or pictures.Complaint history for these part numbers was reviewed for the last 24 months.Three similar complaints were reported for the 1039.C blade and four similar complaints were reported for the 2016.C handle.This failure mode does appear to be trending at this time.Scar 20-007 is currently open with the supplier (conendo) to address this issue.In addition, a project is currently underway, lead by clint pollhill, to change the supplier of this product line to md.The supplier was notified via email.Customer follow up was performed by the sales team member shane street, and all information about similar complaints was relayed through him.This helps the relationship between the sales rep and the customer, and helps with customer perception.Ra: this failure mode (r8), reduced or no visualization due to a nonfunctional light source, is identified on the risk analysis file (ra-44) for intubrite sterile single use laryngoscopes.The severity of harm for this failure mode is considered a moderate (4) risk and does not meet the threshold for carb review (8).Scar 20-007 is currently open to address this issue with the supplier.

• Brand Name: SALTER LABS
• Type of Device: BX20 - PEDIATRIC DISPOSABLE HANDLE 2/BATTERY & BX20 - MILLER 00 DISPOSABLE LED B
• MDR Report Key: 12337340
• MDR Text Key: 268463770
• Report Number: 3000219639-2021-00018
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2016.C & 1039.C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 09/02/2021
• 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