MAUDE Adverse Event Report: SALTER LABS SALTER LABS; PEDIATRIC DISPOSABLE HANDLE 3/BATTERY

Model Number	2016.C
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Light on laryngoscope handle/blade went out after insertion.
Additional Manufacturer Narrative
The light going out during intubation would delay and cause the patient's therapy to be delayed.
Additional Manufacturer Narrative
The light going out during intubation would delay and cause the patient's therapy to be delayed.The complaint of "light on laryngoscope handle/blade went out after insertion" regarding part 2016.C was not confirmed.The root cause was not determined but could possibly be a result of faulty electrical connectivity.A risk assessment was performed, and the ultimate risk was determined to be medium.Capa-00510 is currently open for this issue.There have been 9 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
Light on laryngoscope handle/blade went out after insertion.

• Brand Name: SALTER LABS
• Common Device Name: PEDIATRIC DISPOSABLE HANDLE 3/BATTERY
• 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: 18946340
• Report Number: 3000219639-2024-00032
• Device Sequence Number: 18155640
• Product Code: CCW
• UDI-Device Identifier: 00607411964428
• UDI-Public: 00607411964428
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

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: 2016.C
• Device Catalogue Number: 2016.C
• Device Lot Number: 2022-10-15-ADPS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/25/2024
• 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