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	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Lights not coming on, multiple laryngoscope handles. "we were trying to intubate a baby and the laryngoscope handle light wouldn't come on.We then grabbed a second handle and the light on that one wouldn't come on either this resulted in a delay of care.".
Additional 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.

• 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: 18016401
• Report Number: 3000219639-2023-00035
• Device Sequence Number: 12396423
• Product Code: CCW
• UDI-Device Identifier: 00607411964428
• UDI-Public: 00607411964428
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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 Practitioner
• Type of Report: Initial
• Report Date (Section B): 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 013120ADPS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2023
• 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