MAUDE Adverse Event Report: SALTER LABS SALTER LABS; BX20 - MAC 3 DISPOSABLE LED BLADE

Model Number 1023.C

Device Problem Mechanical Problem (1384)

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

Event Date 08/09/2022

Event Type  malfunction  

Event Description

Blade did not properly light.

Manufacturer Narrative

Failure of the device delayed the intubation of the patient.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.

Manufacturer Narrative

Failure of the device delayed the intubation of the patient.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.The complaint cannot be confirmed.Complaint history reviewed.Light not functioning on intubrite products is a known issue.Reviewed risk file rma-20002b, intubrite std.Laryngoscope, risk analysis.Risk in complaint relates to risk id r8 - reduced or no visualization - light source not functional - s=9, o=2, rpn=18.The severity of 9 > 8 indicates that this issue needs to be brought up to carb.However, this problem has already been brought up to carb and resulted in a supplier change.This event was reported to the fda.Sample parts from the same lot were inspected in the el paso facility from both fg and bf.All samples passed the inspection testing the light functionality.

Event Description

Blade did not properly light.

• Brand Name: SALTER LABS
• Type of Device: BX20 - MAC 3 DISPOSABLE LED BLADE
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 15381681
• MDR Text Key: 305731061
• Report Number: 3000219639-2022-00034
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 10607411966405
• UDI-Public: 10607411966405
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1023.C
• Device Catalogue Number: 1023.C
• Device Lot Number: 2022-01-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other