MAUDE Adverse Event Report: SALTER LABS SALTER LABS; COMBO MILLER 2 DISPOSABLE BLADE..W/ MEDIUM DISPOSABLE HANDLE

Model Number	1032.C2015.C
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
During set up and during intubation our light flickered and/or would not turn on.
Additional 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 "during set up and during intubation our light flickered and/or would not turn on" regarding parts 1023.C2015.C, 1024.C2015.C, and 1032.C2015.C was confirmed.The root cause could possibly be a result of electrical components not making sufficient contact.A risk assessment was performed, and the ultimate risk was determined to be medium which does require reporting to the capa review board.Capa 0510 has already been opened.There have been 0 other complaints regarding the same part 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 or Problem Description
During set up and during intubation our light flickered and/or would not turn on.

• Brand Name: SALTER LABS
• Common Device Name: COMBO MILLER 2 DISPOSABLE BLADE..W/ MEDIUM DISPOSABLE HANDLE
• 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: 19274424
• Report Number: 3000219639-2024-00041
• Device Sequence Number: 6320645
• Product Code: CCW
• UDI-Device Identifier: 00607411403149
• UDI-Public: 00607411403149
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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
• Operator of Device: Health Professional
• Device Model Number: 1032.C2015.C
• Device Catalogue Number: 1032.C2015.C
• Device Lot Number: 26X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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