MAUDE Adverse Event Report: TELEFLEX CORP. RUSCH LARYNGOSCOPE HANDLE

Device Problems Inadequate Lighting (2957); Power Problem (3010)

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

Event Date 12/08/2016

Event Type  Injury  

Event Description

Pt biba to er as code stemi- to cath lab with chest pain, sob, with lad, rca and lcx 99-100% occlusions.Pt deteriorated and intubation was attempted.Laryngoscope blade attached to handle by anesthesia.Light of blade failed to remain on during intubation due to faulty connection and contact to handle which powered light.Delay in intubation- switched handle and intubation was completed.

• Brand Name: RUSCH LARYNGOSCOPE HANDLE
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): TELEFLEX CORP.; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 6175629
• MDR Text Key: 62546379
• Report Number: MW5066708
• Device Sequence Number: 1
• Product Code: CCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR