MAUDE Adverse Event Report: SALTER LABS SALTER LABS INTUBRITE LARYNGOSCOPE

Model Number VLS6630

Device Problem Defective Device (2588)

Patient Problem Respiratory Distress (2045)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

Patient was in cardiac arrest prior to attempted intubation.Customer experienced failed intubation using laryngoscope.Backup airway was used.No serious injury report.

Event Description

Product malfunction.The screen appears to have bubbles under the surface, making it difficult to see.The outer edge of the screen has separated from the screen.

• Brand Name: SALTER LABS INTUBRITE LARYNGOSCOPE
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): SALTER LABS; 2365 camino vida roble; carlsbad CA 92011
• Manufacturer (Section G): SALTER LABS; 2365 camino vida roble; carlsbad CA 92011
• Manufacturer Contact: mara caler ; 2365 camino vida roble; carlsbad, CA 92011 ; 7607957094
• MDR Report Key: 9576910
• MDR Text Key: 174623291
• Report Number: 3000219639-2020-00002
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2020

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
• Device Operator: Health Professional
• Device Model Number: VLS6630
• Device Catalogue Number: VLS6630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other