MAUDE Adverse Event Report: UNKNOWN LARYNGOSCOPE GRADE IV, STYLET RIGID (GLIDESCOPE); LARYNGOSCOPE, RIGID

Device Problem Failure to Power Up (1476)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 12/19/2019

Event Type  malfunction  

Event Description

Asthma, gout and surgical history.Multiple emergency department visits related to asthma.Pt collapsed at work on (b)(6) 2020.Ems called to scene.Rsi intubation attempted using disposable laryngoscope handle and 4 mac (macintosh blade), noted bulb/light would turn on and off while attempting intubation.Intubation attempt abandoned, unable to visualize proper anatomy.Pt being ventilated via bvm.Direct laryngoscopy intubation successful king airway placed, copious amounts of secretions in airway.Placement verified via auscultation, capnography, chest rise, digital etco2, verified by another crew member.During transport, patient coded 4 minutes prior to arrival.Ems initiated cpr.Fda safety report id # (b)(4).

• Brand Name: LARYNGOSCOPE GRADE IV, STYLET RIGID (GLIDESCOPE)
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): UNKNOWN; unknown; unknown
• MDR Report Key: 11207592
• MDR Text Key: 228615444
• Report Number: MW5098934
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): Y
• 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: 01/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 113