MAUDE Adverse Event Report: SALTER LABS SALTER LABS; MEDIUM DISPOSABLE HANDLE

Model Number 2015.C

Device Problem Mechanical Problem (1384)

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

Event Date 08/24/2023

Event Type  malfunction  

Manufacturer Narrative

Failure of the device would delay the intubation of the patient.

Event Description

Laryngoscope handles did not light up.Potential delay in intubation as first two handles did not light up. .

• Brand Name: SALTER LABS
• Type of Device: 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: 18165632
• MDR Text Key: 328643143
• Report Number: 3000219639-2023-00037
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00607411964411
• UDI-Public: 00607411964411
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2015.C
• Device Catalogue Number: 2015.C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other