MAUDE Adverse Event Report: SALTER LABS SALTER LABS; BX20 - MILLER 0 DISPOSABLE LED BLADE

Model Number	1030.C
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Failure of the device delayed the intubation of the patient.
Event or Problem Description
Lights are very dim making it difficult to intubate.
Event or Problem Description
Lights are very dim making it difficult to intubate.
Additional Manufacturer Narrative
Failure of the device delayed the intubation of the patient.Complaint not confirmed due to lack of photo or return.Reviewed complaint history for 24 months preceding reporting date and determined no trending issue.Inspected inventory of similar lot and found no nonconforming units.Root cause could be damage from transport or storage conditions.Performed risk analysis and determined a severity of 6.Sent resolution to the customer.

• Brand Name: SALTER LABS
• Common Device Name: BX20 - MILLER 0 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: 16481820
• Report Number: 3000219639-2023-00007
• Device Sequence Number: 12027989
• Product Code: CCW
• UDI-Device Identifier: 00607411964688
• UDI-Public: 00607411964688
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

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: 1030.C
• Device Catalogue Number: 1030.C
• Device Lot Number: 2022-0101-AMLO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 03/30/2023
• 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