MAUDE Adverse Event Report: SALTER LABS; BX20 - PEDIATRIC DISPOSABLE HANDLE 3/BATTERY

Model Number 2016.C

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 07/28/2021

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 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

Was attempting to intubate and the light failed on the laryngoscope handle and blade.

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 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.Complaint history for this part number was reviewed for the last 24 months.Five similar complaints have been reported.Scar 20-007 is currently open with this supplier to address this issue.In the meantime, heightened inspections at el paso are being performed (lead by josh miller) to prevent the escape of defective product.If a nonconforming lot is identified, an ncmr is initiated and a 100% sort is performed.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 sterile single use laryngoscopes.The severity of harm for this failure mode is considered a moderate (4) risk and does not meet the risk threshold for carb review (8).There is already a scar 20-007 open to address this issue.

Event Description

Was attempting to intubate and the light failed on the laryngoscope handle and blade.

• Brand Name: SALTER LABS
• Type of Device: BX20 - PEDIATRIC DISPOSABLE HANDLE 3/BATTERY
• MDR Report Key: 12373400
• MDR Text Key: 280749120
• Report Number: 3000219639-2021-00022
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

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?: No
• Device Operator: No Information
• Device Model Number: 2016.C
• Device Catalogue Number: 2016.C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 07/29/2021
• Supplement Dates FDA Received: 09/10/2021
• 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