MAUDE Adverse Event Report: AMBU, INC. KING VISION; LARYNGOSCOPE, RIGID

Model Number #3

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 11/27/2019

Event Type  malfunction  

Event Description

During a cardiac arrest case our zoll x-series ekg monitor did not give an ekg tracing in the 4-leads.The monitor was quickly replaced by other units ekg monitor.The delay was approx one min.Cpr was continued during delay.Zoll has been contacted and will conduct testing on the monitor.Our local county ems agency was also notified.During a cardiac arrest case our king vision video laryngoscope failed to operate correctly.The monitor screen was completely green and could not be used.Other airway interventions were continued and the pt was later intubated with a standard laryngoscope.The mfr and local ems agency was also notified of the event.Fda safety report ids# (b)(4).

• Brand Name: KING VISION
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): AMBU, INC.
• MDR Report Key: 9396607
• MDR Text Key: 168787350
• Report Number: MW5091371
• Device Sequence Number: 2
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/27/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: #3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 92 YR
• Patient Weight: 50