MAUDE Adverse Event Report: SALTER LABS SALTER LABS; MAC 3 PLUS DISPOSABLE LED BLADE-MAC 4 DISPOSABLE LED BLADE

Model Number 1024.C-1029.C

Device Problem Mechanical Problem (1384)

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

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

The light going out during intubation would cause a disruption in patient therapy.The clinician would need to find a handle and blade that work further delaying the intubation and patient therapy.

Event Description

The light on the intubrite laryngoscope handles and blades flickers and/or would not turn on. .

Manufacturer Narrative

The light going out during intubation would cause a disruption in patient therapy.The clinician would need to find a handle and blade that work further delaying the intubation and patient therapy.The complaint of "the light on the intubrite laryngoscope handles and blades flickers and/or would not turn on" regarding parts 1024.C/1029.C was not confirmed.The root cause was not determined but could possibly be a result of an internal electrical failure.A risk assessment was performed, and the ultimate risk was determined to be medium which does require reporting to the capa review board.There have been 2 other complaints regarding the same parts and a similar issue within the 24 months preceding the reporting of this issue.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.

Event Description

The light on the intubrite laryngoscope handles and blades flickers and/or would not turn on. .

• Brand Name: SALTER LABS
• Type of Device: MAC 3 PLUS DISPOSABLE LED BLADE-MAC 4 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: 19055614
• MDR Text Key: 339671511
• Report Number: 3000219639-2024-00036
• Device Sequence Number: 1
• Product Code: CCW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

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
• Device Operator: Health Professional
• Device Model Number: 1024.C-1029.C
• Device Catalogue Number: 1024.C-1029.C
• Device Lot Number: 2023-10-10-BMC4,26B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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