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

Model Number	1023.C
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Blade did not properly light.
Additional 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.
Additional 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 or Problem Description
Blade did not properly light.

• Brand Name: SALTER LABS
• Common Device Name: 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
• Report Number: 3000219639-2022-00034
• Device Sequence Number: 17546281
• Product Code: CCW
• UDI-Device Identifier: 10607411966405
• UDI-Public: 10607411966405
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1023.C
• Device Catalogue Number: 1023.C
• Device Lot Number: 2022-01-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown