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 08/10/2022

Event Type  malfunction  

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.

Event Description

Blade did not properly light.

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.Complaint could not be confirmed.Inventory analysis was performed for the part in the complaint.All the inventory pulled passed the inspection.Reviewed the complaint history for the 24 months preceding this event and found 8 previous complaints for light functionality.Reviewed the risk analysis file.This associated failure mode is reduced or no visualization due to a nonfunctional light source.The severity of harm for this failure mode is considered a 9, which typically triggers a carb meeting.However, this has already been brought up at carb meetings and sunmed is going though a supplier change to address the issues.

• 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: 15394999
• MDR Text Key: 305706689
• Report Number: 3000219639-2022-00035
• 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: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• 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: A0320ADSS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2022
• 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