MAUDE Adverse Event Report: KING SYSTEMS CORPORATION AMBU KING VISION VIDEO LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Device Problems Failure to Power Up (1476); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2020

Event Type  malfunction  

Event Description

King vision video laryngoscope.While attempting to intubate a patient during cpr, the video scope turned off during the procedure.The scope was not turned on for more than one minute at that point.After turning off it would not turn back on and stay on.It would turn on and immediately shut back off.Blade was securely attached the entire time and power button was not accidentally pushed to cause the camera to turn off.The laryngoscope was turned on and inspected at the start of the shift on the ambulance and worked as normal.After the pt was transported to the hospital the device was checked and it would turn on and functioned normally after that.This incident only occurred once and was not repeatable.Fda safety report id # (b)(4).

• Brand Name: AMBU KING VISION VIDEO LARYNGOSCOPE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): KING SYSTEMS CORPORATION; noblesville IN 46060
• MDR Report Key: 10792551
• MDR Text Key: 215087213
• Report Number: MW5097665
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2020

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2020
• 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: 65 YR
• Patient Weight: 118