MAUDE Adverse Event Report: SALTER LABS INTUBRITE; LARYNGOSCOPE, RIGID

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2019

Event Type  malfunction  

Event Description

Item is a disposable laryngoscope - light malfunctioned; new laryngoscope acquired.

• Brand Name: INTUBRITE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• MDR Report Key: 8929853
• MDR Text Key: 155546266
• Report Number: 8929853
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/13/2019
• Date Report to Manufacturer: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1